Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (FINCH 3)

• ClinicalTrials.gov Identifier: NCT02886728
• Recruitment Status: Completed
• First Posted: September 1, 2016
• Results First Posted: January 15, 2021
• Last Update Posted: June 1, 2021
• Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Information provided by (Responsible Party): Gilead Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: MTX; Drug: Placebo to match MTX
• Enrollment: 1252

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, and South America. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.
Pre-assignment Details	1855 participants were screened.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Period Title: Overall Study
Started	417	207	210	418
Completed	345	175	174	331
Not Completed	72	32	36	87
Reason Not Completed
Withdrew Consent	31	13	11	47
Lost to Follow-up	12	6	13	12
Adverse Event	13	5	5	11
Investigator's Discretion	11	7	5	11
Death	3	1	0	0
Protocol Violation	0	0	0	4
Non-Compliance with Study Drug	1	0	1	0
Pregnancy	0	0	1	0
Randomized but Not Dosed	1	0	0	2

Baseline Characteristics

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy	Total
Arm/Group Description		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		416	207	210	416	1249
Baseline Analysis Population Description		The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	416 participants	207 participants	210 participants	416 participants	1249 participants
		53 (13.8)	54 (12.6)	52 (13.9)	53 (13.7)	53 (13.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	416 participants	207 participants	210 participants	416 participants	1249 participants
	Female	325	158	166	312	961
	Male	91	49	44	104	288
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	416 participants	207 participants	210 participants	416 participants	1249 participants
	American Indian or Alaska Native	26	12	18	33	89
	Asian: Japanese	23	11	12	25	71
	Asian: Chinese/Taiwanese/Hong Kong Chinese	7	4	6	10	27
	Asian: Vietnamese	1	0	0	0	1
	Asian: Korean	6	8	2	8	24
	Asian: Other	53	28	27	42	150
	Black or African American	15	8	8	14	45
	Native Hawaiian or Pacific Islander	1	0	1	3	5
	White	278	132	135	278	823
	Other	6	4	0	3	13
	Not Permitted	0	0	1	0	1
		[1] Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	416 participants	207 participants	210 participants	416 participants	1249 participants
	Hispanic or Latino	93	40	45	84	262
	Not Hispanic or Latino	322	167	165	332	986
	Not Permitted	1	0	0	0	1
		[1] Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	416 participants	207 participants	210 participants	416 participants	1249 participants
United States		112	47	54	106	319
Spain		12	5	7	10	34
Germany		7	7	6	10	30
South Korea		6	8	2	8	24
Canada		5	5	4	6	20
Belgium		3	2	6	8	19
South Africa		8	5	1	5	19
Australia		7	2	2	7	18
New Zealand		9	3	0	4	16
United Kingdom		1	1	1	5	8
Italy		2	0	1	0	3
Ireland		1	0	0	1	2
Israel		0	0	2	0	2
India		41	21	22	31	115
Poland		35	21	15	37	108
Ukraine		21	10	13	25	69
Bulgaria		17	11	8	18	54
Russia		9	4	4	14	31
Czechia		5	3	3	9	20
Hungary		7	2	3	6	18
Serbia		6	2	4	4	16
Romania		4	1	2	3	10
Slovakia		4	0	2	2	8
Mexico		35	20	23	38	116
Argentina		16	5	4	15	40
Chile		7	3	1	3	14
Taiwan		7	2	5	9	23
Thailand		5	2	1	5	13
Malaysia		1	3	1	1	6
Hong Kong		0	1	1	1	3
Japan		23	11	12	25	71

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24
Description	ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	81.0; (77.1 to 84.9)	80.2; (74.5 to 85.9)	78.1; (72.3 to 83.9)	71.4; (66.9 to 75.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.6
	Confidence Interval	(2-Sided) 95%; 3.6 to 15.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.017
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	8.8
	Confidence Interval	(2-Sided) 95%; 1.5 to 16.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.058
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.7
	Confidence Interval	(2-Sided) 95%; -0.7 to 14.1
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	210 participants	416 participants
		1.52 (0.622)	1.56 (0.654)	1.56 (0.655)	1.60 (0.625)
Change at Week 24	Number Analyzed	372 participants	190 participants	185 participants	370 participants
		-0.94 (0.722)	-0.90 (0.675)	-0.89 (0.631)	-0.79 (0.634)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.27 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.041
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.23 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.049
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.032
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.20 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.050
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24
Description	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.1; (49.2 to 59.0)	42.5; (35.5 to 49.5)	42.4; (35.5 to 49.3)	29.1; (24.6 to 33.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	25.0
	Confidence Interval	(2-Sided) 95%; 18.3 to 31.7
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.4
	Confidence Interval	(2-Sided) 95%; 5.0 to 21.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.3
	Confidence Interval	(2-Sided) 95%; 5.0 to 21.6
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
Description	Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	410 participants	204 participants	204 participants	408 participants
		11.35 (19.922)	13.31 (26.980)	16.53 (32.372)	13.72 (29.168)
Change at Week 24	Number Analyzed	355 participants	184 participants	173 participants	356 participants
		0.21 (1.684)	0.22 (1.526)	-0.04 (1.710)	0.51 (2.887)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.068
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.61 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.161
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.14
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.195
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.199
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	208 participants	416 participants
		33.9 (7.48)	33.7 (8.00)	33.6 (7.70)	33.3 (7.28)
Change at Week 24	Number Analyzed	373 participants	190 participants	185 participants	371 participants
		12.3 (8.89)	11.1 (9.00)	10.4 (9.09)	9.7 (8.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 1.8 to 4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.56
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.021
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 0.2 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.24
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.69
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
Description	FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	411 participants	207 participants	206 participants	415 participants
		28.3 (10.93)	27.3 (11.92)	27.3 (10.90)	27.1 (10.72)
Change at Week 24	Number Analyzed	365 participants	189 participants	181 participants	365 participants
		10.6 (11.49)	11.4 (11.26)	10.2 (11.37)	10.1 (11.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.056
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.0 to 2.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.68
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.10
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.3 to 3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.67
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.3 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.83
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in the mTSS at Week 52
Description	Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Time Frame	Baseline; Week 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	411 participants	205 participants	204 participants	408 participants
		11.31 (19.273)	12.76 (24.363)	15.89 (31.813)	13.36 (27.736)
Change at Week 52	Number Analyzed	345 participants	176 participants	166 participants	330 participants
		0.31 (1.808)	0.23 (1.111)	0.33 (1.902)	0.81 (3.089)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.195
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.236
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -1.14 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.242
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52
Description	ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	42.1; (37.2 to 46.9)	37.2; (30.4 to 44.0)	39.5; (32.7 to 46.4)	16.6; (12.9 to 20.3)
Week 4	62.3; (57.5 to 67.0)	55.6; (48.5 to 62.6)	52.4; (45.4 to 59.4)	33.4; (28.8 to 38.1)
Week 12	76.7; (72.5 to 80.9)	72.0; (65.6 to 78.3)	71.4; (65.1 to 77.8)	59.4; (54.5 to 64.2)
Week 36	75.5; (71.2 to 79.7)	73.4; (67.2 to 79.7)	76.2; (70.2 to 82.2)	68.3; (63.7 to 72.9)
Week 52	75.0; (70.7 to 79.3)	73.4; (67.2 to 79.7)	74.8; (68.6 to 80.9)	61.8; (57.0 to 66.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	25.5
	Confidence Interval	(2-Sided) 95%; 19.3 to 31.7
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	20.6
	Confidence Interval	(2-Sided) 95%; 12.8 to 28.5
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	22.9
	Confidence Interval	(2-Sided) 95%; 15.1 to 30.8
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	28.8
	Confidence Interval	(2-Sided) 95%; 22.1 to 35.6
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	22.1
	Confidence Interval	(2-Sided) 95%; 13.6 to 30.7
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.0
	Confidence Interval	(2-Sided) 95%; 10.5 to 27.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	17.3
	Confidence Interval	(2-Sided) 95%; 10.8 to 23.8
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.6
	Confidence Interval	(2-Sided) 95%; 4.5 to 20.7
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.1
	Confidence Interval	(2-Sided) 95%; 4.0 to 20.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.016
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.2
	Confidence Interval	(2-Sided) 95%; 0.9 to 13.5
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; -2.7 to 13.0
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.9
	Confidence Interval	(2-Sided) 95%; 0.3 to 15.6
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95%; 6.7 to 19.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95%; 3.7 to 19.6
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.0
	Confidence Interval	(2-Sided) 95%; 5.1 to 20.8
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52
Description	ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	13.0; (9.6 to 16.3)	9.2; (5.0 to 13.4)	16.2; (11.0 to 21.4)	2.9; (1.2 to 4.6)
Week 4	29.3; (24.8 to 33.8)	20.8; (15.0 to 26.5)	25.7; (19.6 to 31.9)	9.4; (6.5 to 12.3)
Week 12	53.1; (48.2 to 58.0)	44.4; (37.4 to 51.5)	45.7; (38.7 to 52.7)	28.4; (23.9 to 32.8)
Week 24	61.5; (56.7 to 66.3)	57.0; (50.0 to 64.0)	58.1; (51.2 to 65.0)	45.7; (40.8 to 50.6)
Week 36	60.6; (55.8 to 65.4)	55.6; (48.5 to 62.6)	58.6; (51.7 to 65.5)	48.6; (43.6 to 53.5)
Week 52	62.3; (57.5 to 67.0)	59.4; (52.5 to 66.4)	61.4; (54.6 to 68.3)	48.3; (43.4 to 53.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.1
	Confidence Interval	(2-Sided) 95%; 6.2 to 13.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 1.7 to 10.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.3
	Confidence Interval	(2-Sided) 95%; 7.7 to 18.9
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	20.0
	Confidence Interval	(2-Sided) 95%; 14.5 to 25.4
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.4
	Confidence Interval	(2-Sided) 95%; 4.8 to 18.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.3
	Confidence Interval	(2-Sided) 95%; 9.4 to 23.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	24.8
	Confidence Interval	(2-Sided) 95%; 18.1 to 31.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.1
	Confidence Interval	(2-Sided) 95%; 7.7 to 24.5
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	17.3
	Confidence Interval	(2-Sided) 95%; 9.0 to 25.7
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	15.9
	Confidence Interval	(2-Sided) 95%; 8.9 to 22.8
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.3
	Confidence Interval	(2-Sided) 95%; 2.7 to 20.0
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.4
	Confidence Interval	(2-Sided) 95%; 3.9 to 21.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.0
	Confidence Interval	(2-Sided) 95%; 5.1 to 19.0
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.090
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; -1.7 to 15.7
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.014
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.0
	Confidence Interval	(2-Sided) 95%; 1.4 to 18.6
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.9
	Confidence Interval	(2-Sided) 95%; 7.0 to 20.9
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.1
	Confidence Interval	(2-Sided) 95%; 2.5 to 19.7
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.1
	Confidence Interval	(2-Sided) 95%; 4.6 to 21.6
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52
Description	ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	3.1; (1.3 to 4.9)	1.9; (0.0 to 4.0)	4.3; (1.3 to 7.3)	0.7; (0.0 to 1.7)
Week 4	13.0; (9.6 to 16.3)	6.3; (2.7 to 9.8)	11.4; (6.9 to 16.0)	3.8; (1.9 to 5.8)
Week 12	32.9; (28.3 to 37.6)	27.1; (20.8 to 33.3)	29.0; (22.7 to 35.4)	13.2; (9.8 to 16.6)
Week 24	43.8; (38.9 to 48.6)	40.1; (33.2 to 47.0)	40.0; (33.1 to 46.9)	26.0; (21.6 to 30.3)
Week 36	45.9; (41.0 to 50.8)	37.2; (30.4 to 44.0)	39.5; (32.7 to 46.4)	32.2; (27.6 to 36.8)
Week 52	47.8; (42.9 to 52.8)	40.1; (33.2 to 47.0)	45.2; (38.3 to 52.2)	29.8; (25.3 to 34.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.018
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 0.3 to 4.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.17
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -1.2 to 3.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 0.3 to 6.8
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.1
	Confidence Interval	(2-Sided) 95%; 5.2 to 13.1
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; -1.7 to 6.6
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 2.5 to 12.6
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.7
	Confidence Interval	(2-Sided) 95%; 13.9 to 25.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.8
	Confidence Interval	(2-Sided) 95%; 6.6 to 21.1
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	15.8
	Confidence Interval	(2-Sided) 95%; 8.5 to 23.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	17.8
	Confidence Interval	(2-Sided) 95%; 11.2 to 24.4
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.1
	Confidence Interval	(2-Sided) 95%; 5.9 to 22.4
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.0
	Confidence Interval	(2-Sided) 95%; 5.8 to 22.2
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.7
	Confidence Interval	(2-Sided) 95%; 6.9 to 20.5
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; -3.3 to 13.3
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.056
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; -1.0 to 15.7
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.0
	Confidence Interval	(2-Sided) 95%; 11.3 to 24.8
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 1.9 to 18.6
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	15.4
	Confidence Interval	(2-Sided) 95%; 7.0 to 23.8
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability).
Time Frame	Baseline; Weeks 2, 4, 12, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	210 participants	416 participants
		1.52 (0.622)	1.56 (0.654)	1.56 (0.655)	1.60 (0.625)
Change at Week 2	Number Analyzed	400 participants	202 participants	202 participants	405 participants
		-0.37 (0.495)	-0.36 (0.490)	-0.32 (0.442)	-0.18 (0.426)
Change at Week 4	Number Analyzed	405 participants	200 participants	205 participants	403 participants
		-0.57 (0.587)	-0.45 (0.547)	-0.51 (0.526)	-0.32 (0.511)
Change at Week 12	Number Analyzed	389 participants	197 participants	193 participants	389 participants
		-0.85 (0.698)	-0.77 (0.670)	-0.76 (0.625)	-0.61 (0.582)
Change at Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		-0.96 (0.725)	-0.93 (0.700)	-0.91 (0.673)	-0.89 (0.675)
Change at Week 52	Number Analyzed	332 participants	169 participants	171 participants	307 participants
		-1.00 (0.728)	-0.97 (0.719)	-0.95 (0.688)	-0.88 (0.685)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95%; -0.29 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.031
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.28 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.038
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.24 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.038
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.035
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.23 to -0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.043
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.29 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.042
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 95%; -0.35 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.039
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.28 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.048
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.26 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.048
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.22 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.043
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.23
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.052
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.24
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.16 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.052
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.25 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.045
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.077
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.20 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.054
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.039
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 95%; -0.22 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.054
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52
Description	TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: tender joint count
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		26 (14.5)	25 (13.9)	26 (13.7)	26 (13.8)
Change at Week 2	Number Analyzed	402 participants	202 participants	201 participants	405 participants
		-9 (10.2)	-8 (9.8)	-9 (11.2)	-5 (9.8)
Change at Week 4	Number Analyzed	408 participants	201 participants	205 participants	404 participants
		-13 (12.1)	-12 (10.1)	-13 (11.8)	-8 (11.5)
Change at Week 12	Number Analyzed	390 participants	197 participants	193 participants	387 participants
		-18 (12.5)	-17 (12.4)	-18 (12.4)	-15 (12.2)
Change at Week 24	Number Analyzed	374 participants	190 participants	186 participants	370 participants
		-20 (12.5)	-20 (13.0)	-22 (12.4)	-19 (12.9)
Change at Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		-21 (12.6)	-21 (12.8)	-23 (11.9)	-21 (12.7)
Change at Week 52	Number Analyzed	332 participants	170 participants	171 participants	307 participants
		-22 (12.4)	-21 (13.0)	-23 (12.3)	-21 (12.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.7
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.063
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.64
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.095
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52
Description	The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: swollen joint count
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		16.0 (9.8)	16.0 (9.3)	16.0 (9.7)	16.0 (9.4)
Change at Week 2	Number Analyzed	402 participants	202 participants	201 participants	405 participants
		-7.0 (8.0)	-6.0 (6.9)	-7.0 (8.1)	-4.0 (7.5)
Change at Week 4	Number Analyzed	408 participants	201 participants	205 participants	404 participants
		-9.0 (8.7)	-9.0 (7.6)	-9.0 (8.3)	-6.0 (9.2)
Change at Week 12	Number Analyzed	390 participants	197 participants	193 participants	387 participants
		-13.0 (8.9)	-12.0 (8.1)	-13.0 (9.1)	-11.0 (8.9)
Change at Week 24	Number Analyzed	374 participants	190 participants	186 participants	370 participants
		-14.0 (8.9)	-14.0 (8.8)	-15.0 (9.5)	-13.0 (8.8)
Change at Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		-14.0 (9.1)	-14.0 (9.4)	-15.0 (9.7)	-14.0 (8.7)
Change at Week 52	Number Analyzed	332 participants	170 participants	171 participants	307 participants
		-15.0 (9.2)	-14.0 (8.9)	-16.0 (9.8)	-14.0 (9.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.7
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	Mixed effects model for repeated measure
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.12
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.019
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.032
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52
Description	SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		65.0 (21.0)	66.0 (21.6)	68.0 (19.2)	66.0 (21.0)
Change at Week 2	Number Analyzed	401 participants	201 participants	202 participants	407 participants
		-17.0 (20.8)	-13.0 (18.9)	-14.0 (20.7)	-7.0 (18.9)
Change at Week 4	Number Analyzed	407 participants	200 participants	205 participants	404 participants
		-26.0 (24.7)	-20.0 (22.5)	-22.0 (24.6)	-14.0 (22.2)
Change at Week 12	Number Analyzed	391 participants	196 participants	192 participants	389 participants
		-37.0 (26.7)	-30.0 (26.1)	-32.0 (27.7)	-25.0 (25.9)
Change at Week 24	Number Analyzed	374 participants	190 participants	184 participants	370 participants
		-42.0 (26.8)	-36.0 (27.4)	-38.0 (26.6)	-34.0 (27.4)
Change at Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		-43.0 (27.2)	-39.0 (27.8)	-39.0 (24.3)	-38.0 (28.0)
Change at Week 52	Number Analyzed	332 participants	170 participants	171 participants	307 participants
		-45.0 (27.0)	-41.0 (28.1)	-43.0 (25.4)	-38.0 (28.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-11.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-12.0
	Confidence Interval	(2-Sided) 95%; -15.0 to -10.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-12.0
	Confidence Interval	(2-Sided) 95%; -15.0 to -9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -9.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -7.0 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.066
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -8.0 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.40
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.0 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.24
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.0 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.17
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -7.0 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52
Description	PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		66.0 (17.0)	68.0 (16.3)	66.0 (14.4)	67.0 (16.8)
Change at Week 2	Number Analyzed	397 participants	200 participants	201 participants	401 participants
		-24.0 (20.3)	-21.0 (19.4)	-23.0 (19.9)	-15.0 (18.9)
Change at Week 4	Number Analyzed	402 participants	201 participants	198 participants	402 participants
		-34.0 (22.3)	-32.0 (22.5)	-30.0 (21.9)	-23.0 (20.7)
Change at Week 12	Number Analyzed	388 participants	196 participants	192 participants	385 participants
		-47.0 (21.4)	-43.0 (22.5)	-42.0 (20.8)	-38.0 (21.9)
Change at Week 24	Number Analyzed	372 participants	187 participants	185 participants	364 participants
		-51.0 (21.1)	-51.0 (22.2)	-49.0 (19.5)	-46.0 (21.4)
Change at Week 36	Number Analyzed	347 participants	177 participants	178 participants	324 participants
		-53.0 (20.5)	-51.0 (22.3)	-52.0 (18.6)	-51.0 (20.6)
Change at Week 52	Number Analyzed	332 participants	169 participants	171 participants	307 participants
		-56.0 (20.0)	-54.0 (20.7)	-55.0 (17.5)	-51.0 (20.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -9.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-11.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -9.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -8.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -8.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.046
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.44
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -4.0 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.21
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -5.0 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.029
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -6.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52
Description	The participant assessed their pain severity using a VAS on a scale of 0 ( no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	210 participants	416 participants
		64.0 (22.0)	67.0 (22.1)	67.0 (18.4)	66.0 (21.4)
Change at Week 2	Number Analyzed	400 participants	202 participants	202 participants	405 participants
		-18.0 (22.2)	-15.0 (20.3)	-17.0 (21.6)	-7.0 (20.1)
Change at Week 4	Number Analyzed	405 participants	200 participants	205 participants	403 participants
		-26.0 (24.8)	-22.0 (23.7)	-24.0 (25.3)	-14.0 (23.6)
Change at Week 12	Number Analyzed	389 participants	197 participants	193 participants	389 participants
		-37.0 (27.1)	-31.0 (26.9)	-32.0 (28.3)	-26.0 (27.0)
Change at Week 24	Number Analyzed	372 participants	190 participants	185 participants	370 participants
		-41.0 (28.0)	-37.0 (27.8)	-39.0 (26.1)	-34.0 (27.6)
Change at Week 36	Number Analyzed	348 participants	178 participants	179 participants	326 participants
		-43.0 (28.0)	-40.0 (28.8)	-38.0 (25.6)	-38.0 (29.3)
Change at Week 52	Number Analyzed	332 participants	169 participants	171 participants	307 participants
		-45.0 (27.9)	-43.0 (27.9)	-44.0 (24.2)	-37.0 (30.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-12.0
	Confidence Interval	(2-Sided) 95%; -15.0 to -9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-13.0
	Confidence Interval	(2-Sided) 95%; -16.0 to -10.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-12.0
	Confidence Interval	(2-Sided) 95%; -15.0 to -8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.019
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5
	Confidence Interval	(2-Sided) 95.0%; -9.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.13
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -7.0 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.047
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -8.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.34
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.0 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.46
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.0 to 3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -9.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.2
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.2
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
Description	[Not Specified]
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: mg/L
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		18.04 (25.289)	17.72 (27.419)	17.32 (23.228)	16.86 (24.353)
Change at Week 2	Number Analyzed	404 participants	200 participants	204 participants	400 participants
		-12.89 (23.401)	-9.40 (18.930)	-10.97 (20.249)	-0.99 (14.392)
Change at Week 4	Number Analyzed	404 participants	200 participants	203 participants	402 participants
		-13.79 (23.569)	-11.53 (20.596)	-10.95 (23.319)	-3.18 (18.534)
Change at Week 12	Number Analyzed	388 participants	196 participants	190 participants	383 participants
		-13.77 (23.585)	-11.02 (20.272)	-12.04 (24.690)	-7.23 (21.823)
Change at Week 24	Number Analyzed	374 participants	190 participants	186 participants	368 participants
		-13.43 (27.086)	-10.85 (24.458)	-12.66 (24.525)	-7.47 (23.511)
Change at Week 36	Number Analyzed	348 participants	177 participants	177 participants	321 participants
		-12.99 (26.823)	-12.64 (22.736)	-11.52 (26.863)	-8.74 (23.579)
Change at Week 52	Number Analyzed	332 participants	170 participants	170 participants	307 participants
		-13.84 (25.180)	-11.61 (23.857)	-12.29 (23.090)	-7.96 (23.835)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-10.78
	Confidence Interval	(2-Sided) 95%; -12.71 to -8.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.983
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.76
	Confidence Interval	(2-Sided) 95%; -11.13 to -6.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.207
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.64
	Confidence Interval	(2-Sided) 95%; -12.00 to -7.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.200
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.92
	Confidence Interval	(2-Sided) 95%; -11.65 to -8.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.884
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.34
	Confidence Interval	(2-Sided) 95%; -10.47 to -6.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.086
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.33
	Confidence Interval	(2-Sided) 95%; -9.45 to -5.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.080
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.98
	Confidence Interval	(2-Sided) 95%; -7.56 to -4.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.808
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.21
	Confidence Interval	(2-Sided) 95%; -6.14 to -2.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.987
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.34
	Confidence Interval	(2-Sided) 95%; -6.29 to -2.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.993
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.27
	Confidence Interval	(2-Sided) 95%; -7.24 to -3.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.003
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.29
	Confidence Interval	(2-Sided) 95%; -5.68 to -0.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.222
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.61
	Confidence Interval	(2-Sided) 95%; -7.02 to -2.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.229
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.44
	Confidence Interval	(2-Sided) 95%; -5.35 to -1.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.974
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.40
	Confidence Interval	(2-Sided) 95%; -5.72 to -1.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.180
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.072
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.12
	Confidence Interval	(2-Sided) 95%; -4.44 to 0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.180
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.79
	Confidence Interval	(2-Sided) 95%; -6.34 to -3.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.789
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.01
	Confidence Interval	(2-Sided) 95%; -4.88 to -1.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.957
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.77
	Confidence Interval	(2-Sided) 95%; -5.65 to -1.89
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.957
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		61.9; (57.1 to 66.8)	58.5; (51.4 to 65.6)	53.9; (46.8 to 61.0)	42.2; (37.3 to 47.1)
Week 4	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		72.4; (67.9 to 76.9)	61.0; (54.0 to 68.0)	68.6; (62.0 to 75.2)	53.9; (49.0 to 58.8)
Week 12	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		80.3; (76.3 to 84.4)	74.5; (68.2 to 80.8)	74.0; (67.8 to 80.3)	69.8; (65.2 to 74.3)
Week 24	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		76.6; (72.4 to 80.9)	78.5; (72.6 to 84.4)	77.0; (70.9 to 83.0)	73.9; (69.5 to 78.3)
Week 36	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		73.4; (68.9 to 77.8)	76.5; (70.4 to 82.6)	73.5; (67.2 to 79.8)	67.1; (62.4 to 71.7)
Week 52	Number Analyzed	402 participants	200 participants	204 participants	410 participants
		70.9; (66.3 to 75.5)	71.5; (65.0 to 78.0)	70.6; (64.1 to 77.1)	61.0; (56.1 to 65.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.7
	Confidence Interval	(2-Sided) 95%; 12.8 to 26.7
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.3
	Confidence Interval	(2-Sided) 95%; 7.6 to 25.0
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95%; 3.0 to 20.4
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.5
	Confidence Interval	(2-Sided) 95%; 11.7 to 25.2
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.083
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.1
	Confidence Interval	(2-Sided) 95%; -1.6 to 15.8
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 6.4 to 23.1
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.6
	Confidence Interval	(2-Sided) 95%; 4.4 to 16.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.22
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; -3.1 to 12.6
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.3
	Confidence Interval	(2-Sided) 95%; -3.6 to 12.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.35
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; -3.5 to 8.9
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.6
	Confidence Interval	(2-Sided) 95%; -2.9 to 12.1
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.36
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; -4.5 to 10.6
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.043
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; -0.2 to 12.8
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.015
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.4
	Confidence Interval	(2-Sided) 95%; 1.6 to 17.2
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.085
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -1.5 to 14.4
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; 3.2 to 16.6
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.5
	Confidence Interval	(2-Sided) 95%; 2.3 to 18.7
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.014
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.6
	Confidence Interval	(2-Sided) 95%; 1.4 to 17.8
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52
Description	The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		5.7 (0.99)	5.7 (1.04)	5.8 (0.94)	5.7 (1.00)
Change at Week 2	Number Analyzed	399 participants	199 participants	200 participants	396 participants
		-1.3 (1.06)	-1.1 (0.92)	-1.4 (1.12)	-0.6 (0.87)
Change at Week 4	Number Analyzed	403 participants	199 participants	202 participants	401 participants
		-1.9 (1.26)	-1.6 (1.14)	-1.8 (1.20)	-1.0 (1.04)
Change at Week 12	Number Analyzed	386 participants	195 participants	189 participants	380 participants
		-2.7 (1.31)	-2.5 (1.28)	-2.6 (1.26)	-1.9 (1.21)
Change at Week 24	Number Analyzed	374 participants	190 participants	183 participants	368 participants
		-3.2 (1.31)	-2.9 (1.30)	-3.0 (1.16)	-2.5 (1.29)
Change at Week 36	Number Analyzed	347 participants	177 participants	177 participants	321 participants
		-3.3 (1.28)	-3.0 (1.26)	-3.2 (1.12)	-2.9 (1.22)
Change at Week 52	Number Analyzed	332 participants	170 participants	169 participants	307 participants
		-3.4 (1.23)	-3.1 (1.24)	-3.3 (1.11)	-2.8 (1.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.1 to -0.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -1.0 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -0.8 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.033
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.4 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -0.8 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52
Description	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 4, 12, 24, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 4	30.8; (26.2 to 35.3)	23.7; (17.6 to 29.7)	31.9; (25.4 to 38.4)	12.0; (8.8 to 15.3)
Week 12	55.8; (50.9 to 60.7)	50.2; (43.2 to 57.3)	48.1; (41.1 to 55.1)	28.6; (24.1 to 33.1)
Week 24	68.8; (64.2 to 73.3)	62.8; (56.0 to 69.6)	60.0; (53.1 to 66.9)	46.2; (41.2 to 51.1)
Week 52	69.0; (64.4 to 73.6)	59.9; (53.0 to 66.8)	65.7; (59.1 to 72.4)	47.6; (42.7 to 52.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.8
	Confidence Interval	(2-Sided) 95%; 13.1 to 24.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.7
	Confidence Interval	(2-Sided) 95%; 4.7 to 18.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.9
	Confidence Interval	(2-Sided) 95%; 12.5 to 27.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	27.2
	Confidence Interval	(2-Sided) 95%; 20.5 to 33.9
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	21.6
	Confidence Interval	(2-Sided) 95%; 13.2 to 30.1
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.5
	Confidence Interval	(2-Sided) 95%; 11.1 to 27.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	22.6
	Confidence Interval	(2-Sided) 95%; 15.8 to 29.4
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.6
	Confidence Interval	(2-Sided) 95%; 8.1 to 25.2
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.8
	Confidence Interval	(2-Sided) 95%; 5.3 to 22.4
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	21.4
	Confidence Interval	(2-Sided) 95%; 14.6 to 28.2
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.3
	Confidence Interval	(2-Sided) 95%; 3.7 to 20.9
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.1
	Confidence Interval	(2-Sided) 95%; 9.7 to 26.5
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52
Description	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed	416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	7.2; (4.6 to 9.8)	4.3; (1.3 to 7.4)	10.0; (5.7 to 14.3)	1.0; (0.0 to 2.0)
Week 4	16.6; (12.9 to 20.3)	15.0; (9.9 to 20.1)	19.5; (13.9 to 25.1)	4.8; (2.6 to 7.0)
Week 12	39.7; (34.8 to 44.5)	31.9; (25.3 to 38.5)	29.5; (23.1 to 35.9)	17.1; (13.3 to 20.8)
Week 36	52.6; (47.7 to 57.6)	42.0; (35.1 to 49.0)	43.3; (36.4 to 50.3)	34.4; (29.7 to 39.1)
Week 52	53.4; (48.5 to 58.3)	43.0; (36.0 to 50.0)	46.2; (39.2 to 53.2)	31.5; (26.9 to 36.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 3.4 to 9.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	3.4
	Confidence Interval	(2-Sided) 95%; 0.1 to 6.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.0
	Confidence Interval	(2-Sided) 95%; 4.5 to 13.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.8
	Confidence Interval	(2-Sided) 95%; 7.4 to 16.1
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 4.5 to 15.8
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 8.6 to 20.8
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	22.6
	Confidence Interval	(2-Sided) 95%; 16.4 to 28.8
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.8
	Confidence Interval	(2-Sided) 95%; 7.1 to 22.5
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.5
	Confidence Interval	(2-Sided) 95%; 4.9 to 20.0
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.3
	Confidence Interval	(2-Sided) 95%; 11.4 to 25.1
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.056
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.7
	Confidence Interval	(2-Sided) 95%; -0.8 to 16.1
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	9.0
	Confidence Interval	(2-Sided) 95%; 0.5 to 17.4
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	21.9
	Confidence Interval	(2-Sided) 95%; 15.1 to 28.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.5
	Confidence Interval	(2-Sided) 95%; 3.1 to 20.0
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 6.3 to 23.1
	Estimation Comments	[Not Specified]

22. Secondary Outcome

Title	ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52
Description	ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Time Frame	Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percent improvement
Week 2	Number Analyzed	386 participants	191 participants	197 participants	387 participants
		20.8 (21.42)	17.8 (20.07)	20.9 (23.19)	8.9 (14.95)
Week 4	Number Analyzed	389 participants	192 participants	193 participants	395 participants
		34.1 (27.78)	27.6 (24.81)	29.4 (27.86)	17.2 (21.43)
Week 12	Number Analyzed	377 participants	188 participants	185 participants	375 participants
		52.6 (29.91)	46.1 (31.46)	48.6 (30.50)	34.3 (28.07)
Week 24	Number Analyzed	365 participants	181 participants	180 participants	359 participants
		62.8 (28.40)	58.1 (30.19)	59.7 (29.35)	49.0 (29.46)
Week 36	Number Analyzed	341 participants	170 participants	173 participants	315 participants
		65.8 (28.50)	58.7 (30.99)	62.1 (28.12)	57.3 (29.16)
Week 52	Number Analyzed	327 participants	163 participants	166 participants	304 participants
		69.6 (27.38)	63.6 (29.19)	67.4 (26.60)	57.1 (29.59)

23. Secondary Outcome

Title	Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52
Description	Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2.
Time Frame	Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	Number Analyzed	399 participants	199 participants	200 participants	396 participants
	Good Response	66	21	35	20
	Moderate Response	199	92	88	118
	No Response	134	86	77	258
Week 4	Number Analyzed	403 participants	199 participants	202 participants	401 participants
	Good Response	120	45	63	45
	Moderate Response	206	104	97	161
	No Response	77	50	42	195
Week 12	Number Analyzed	386 participants	195 participants	189 participants	380 participants
	Good Response	230	100	98	116
	Moderate Response	130	79	77	190
	No Response	26	16	14	74
Week 24	Number Analyzed	374 participants	190 participants	183 participants	368 participants
	Good Response	283	127	126	186
	Moderate Response	82	55	52	153
	No Response	9	8	5	29
Week 36	Number Analyzed	347 participants	177 participants	177 participants	321 participants
	Good Response	276	118	124	208
	Moderate Response	64	54	51	106
	No Response	7	5	2	7
Week 52	Number Analyzed	332 participants	170 participants	169 participants	307 participants
	Good Response	286	123	136	194
	Moderate Response	43	43	30	102
	No Response	3	4	3	11

24. Secondary Outcome

Title	Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52
Description	CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		39.5 (12.77)	39.2 (12.69)	40.0 (12.63)	40.2 (12.50)
Change at Week 2	Number Analyzed	396 participants	199 participants	201 participants	401 participants
		-13.6 (12.05)	-12.0 (10.54)	-13.9 (12.53)	-8.5 (11.33)
Change at Week 4	Number Analyzed	401 participants	200 participants	198 participants	402 participants
		-19.9 (13.64)	-17.8 (12.06)	-18.4 (12.96)	-13.3 (12.61)
Change at Week 12	Number Analyzed	388 participants	195 participants	191 participants	384 participants
		-27.8 (13.60)	-26.1 (13.00)	-27.5 (13.55)	-22.7 (13.38)
Change at Week 24	Number Analyzed	372 participants	187 participants	184 participants	364 participants
		-31.3 (13.19)	-30.0 (13.32)	-31.3 (12.57)	-28.2 (13.43)
Change at Week 36	Number Analyzed	347 participants	177 participants	178 participants	324 participants
		-32.2 (13.37)	-30.8 (12.84)	-32.7 (12.16)	-31.3 (12.66)
Change at Week 52	Number Analyzed	332 participants	169 participants	171 participants	307 participants
		-33.8 (13.00)	-31.9 (12.22)	-33.6 (12.28)	-31.2 (13.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -7.3 to -4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.4
	Confidence Interval	(2-Sided) 95%; -6.4 to -2.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.01
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -7.7 to -3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.01
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.3
	Confidence Interval	(2-Sided) 95%; -8.9 to -5.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.83
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.3
	Confidence Interval	(2-Sided) 95%; -7.3 to -3.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.02
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -7.8 to -3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.02
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.8
	Confidence Interval	(2-Sided) 95%; -7.3 to -4.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.4
	Confidence Interval	(2-Sided) 95%; -6.1 to -2.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.88
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.1
	Confidence Interval	(2-Sided) 95%; -6.8 to -3.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.88
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.1
	Confidence Interval	(2-Sided) 95%; -5.3 to -2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.8
	Confidence Interval	(2-Sided) 95%; -4.3 to -1.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 95%; -4.4 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -3.4 to -1.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.36
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -2.0 to 0.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -3.3 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.3
	Confidence Interval	(2-Sided) 95%; -4.5 to -2.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.56
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.042
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -2.7 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -3.7 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.69
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52
Description	SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	416 participants	207 participants	210 participants	416 participants
		41.3 (13.41)	41.0 (13.53)	41.8 (13.09)	41.9 (13.39)
Change at Week 2	Number Analyzed	394 participants	197 participants	200 participants	392 participants
		-14.9 (12.45)	-12.9 (10.84)	-15.0 (12.82)	-8.6 (11.49)
Change at Week 4	Number Analyzed	397 participants	199 participants	196 participants	399 participants
		-21.3 (14.17)	-19.0 (12.58)	-19.6 (13.38)	-13.7 (12.83)
Change at Week 12	Number Analyzed	384 participants	194 participants	188 participants	378 participants
		-29.2 (14.05)	-27.1 (13.59)	-28.6 (14.02)	-23.5 (13.82)
Change at Week 24	Number Analyzed	372 participants	187 participants	183 participants	362 participants
		-32.7 (13.83)	-31.1 (14.09)	-32.7 (13.14)	-29.0 (14.09)
Change at Week 36	Number Analyzed	346 participants	176 participants	176 participants	318 participants
		-33.5 (14.02)	-32.1 (13.61)	-33.9 (12.67)	-32.3 (13.47)
Change at Week 52	Number Analyzed	332 participants	169 participants	169 participants	307 participants
		-35.2 (13.68)	-33.0 (13.12)	-35.0 (12.69)	-32.0 (14.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.8
	Confidence Interval	(2-Sided) 95%; -8.5 to -5.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.85
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.3
	Confidence Interval	(2-Sided) 95%; -7.3 to -3.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.7
	Confidence Interval	(2-Sided) 95%; -8.8 to -4.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.03
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.3
	Confidence Interval	(2-Sided) 95%; -9.9 to -6.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.85
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.2
	Confidence Interval	(2-Sided) 95%; -8.2 to -4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95%; -8.5 to -4.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.04
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95%; -8.0 to -5.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.74
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.8
	Confidence Interval	(2-Sided) 95%; -6.5 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.90
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.6
	Confidence Interval	(2-Sided) 95%; -7.4 to -3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.90
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 95%; -5.9 to -3.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -4.6 to -1.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -4.9 to -1.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.79
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -3.8 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.23
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -2.4 to 0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.74
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.1
	Confidence Interval	(2-Sided) 95%; -3.6 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.60
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.021
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -3.1 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.73
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.8
	Confidence Interval	(2-Sided) 95%; -4.3 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.73
	Estimation Comments	[Not Specified]

26. Secondary Outcome

Title	Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52
Description	Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC).
Time Frame	Baseline; Weeks 24, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 24: Change in mTSS ≤ 0.5	Number Analyzed	355 participants	184 participants	173 participants	356 participants
		89.6; (86.3 to 92.9)	87.0; (81.8 to 92.1)	89.6; (84.8 to 94.4)	82.0; (77.9 to 86.2)
Week 24: Change in mTSS ≤ 0	Number Analyzed	355 participants	184 participants	173 participants	356 participants
		80.6; (76.3 to 84.8)	76.6; (70.2 to 83.0)	82.7; (76.7 to 88.6)	72.5; (67.7 to 77.3)
Week 24: Change in mTSS ≤ SDC (1.53)	Number Analyzed	355 participants	184 participants	173 participants	356 participants
		95.2; (92.8 to 97.6)	93.5; (89.6 to 97.3)	96.0; (92.7 to 99.2)	91.6; (88.5 to 94.6)
Week 52: Change in mTSS ≤ 0.5	Number Analyzed	345 participants	176 participants	166 participants	330 participants
		88.1; (84.6 to 91.7)	85.8; (80.4 to 91.2)	84.3; (78.5 to 90.2)	77.9; (73.2 to 82.5)
Week 52: Change in mTSS ≤ 0	Number Analyzed	345 participants	176 participants	166 participants	330 participants
		80.6; (76.3 to 84.9)	76.1; (69.6 to 82.7)	77.1; (70.4 to 83.8)	70.6; (65.5 to 75.7)
Week 52: Change in mTSS ≤ SDC (1.77)	Number Analyzed	345 participants	176 participants	166 participants	330 participants
		94.2; (91.6 to 96.8)	94.9; (91.3 to 98.4)	89.2; (84.1 to 94.2)	86.7; (82.8 to 90.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 2.2 to 12.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.16
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.9
	Confidence Interval	(2-Sided) 95%; -1.8 to 11.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.029
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 1.1 to 14.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.015
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	8.1
	Confidence Interval	(2-Sided) 95%; 1.6 to 14.6
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.33
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95%; -3.9 to 12.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.013
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 2.5 to 17.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.074
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; -0.3 to 7.6
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.49
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -3.1 to 6.9
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.075
	Comments	P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.4
	Confidence Interval	(2-Sided) 95%; -0.2 to 8.9
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 4.3 to 16.2
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.045
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.9
	Confidence Interval	(2-Sided) 95%; 0.7 to 15.2
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.100
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -1.1 to 14.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.0
	Confidence Interval	(2-Sided) 95%; 3.2 to 16.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	5.5
	Confidence Interval	(2-Sided) 95%; -2.9 to 14.0
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.14
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -2.0 to 15.0
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.5
	Confidence Interval	(2-Sided) 95%; 2.8 to 12.3
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	8.2
	Confidence Interval	(2-Sided) 95%; 2.9 to 13.6
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.47
	Comments	P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; -3.9 to 8.9
	Estimation Comments	[Not Specified]

27. Secondary Outcome

Title	SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	408 participants	203 participants	205 participants	411 participants
		40.6 (8.04)	39.2 (8.86)	39.6 (8.46)	37.0 (8.13)
Week 12	Number Analyzed	394 participants	198 participants	195 participants	389 participants
		45.0 (8.42)	42.9 (9.71)	42.7 (9.90)	40.9 (8.10)
Week 24	Number Analyzed	375 participants	190 participants	187 participants	371 participants
		46.3 (8.16)	44.8 (9.39)	44.1 (9.42)	43.0 (8.36)
Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		46.6 (8.17)	45.2 (9.42)	45.0 (8.89)	44.4 (8.39)
Week 52	Number Analyzed	333 participants	169 participants	172 participants	307 participants
		47.4 (8.35)	45.6 (9.02)	45.9 (9.40)	44.5 (8.32)

28. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time Frame	Baseline; Weeks 4, 12, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	208 participants	416 participants
		33.9 (7.48)	33.7 (8.00)	33.6 (7.70)	33.3 (7.28)
Change at Week 4	Number Analyzed	406 participants	203 participants	203 participants	411 participants
		6.8 (6.86)	5.3 (6.90)	5.9 (7.53)	3.8 (6.38)
Change at Week 12	Number Analyzed	392 participants	198 participants	193 participants	389 participants
		11.2 (8.66)	9.1 (8.82)	8.9 (9.17)	7.6 (7.64)
Change at Week 36	Number Analyzed	346 participants	178 participants	177 participants	327 participants
		12.4 (9.30)	11.7 (8.52)	11.2 (8.54)	11.3 (9.04)
Change at Week 52	Number Analyzed	331 participants	169 participants	170 participants	307 participants
		13.4 (9.62)	12.0 (8.47)	11.9 (9.22)	11.2 (9.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95%; 2.4 to 4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.45
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 0.7 to 2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 1.3 to 3.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; 2.7 to 4.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.54
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.5 to 3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 0.2 to 2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 0.6 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.38
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -0.8 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.59
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; 1.6 to 4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.62
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.3 to 2.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.76
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.071
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.17 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.76
	Estimation Comments	[Not Specified]

29. Secondary Outcome

Title	SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	408 participants	203 participants	205 participants	411 participants
		48.7 (9.73)	46.9 (10.42)	47.5 (10.46)	45.5 (11.38)
Week 12	Number Analyzed	394 participants	198 participants	195 participants	389 participants
		49.9 (9.49)	49.2 (9.99)	48.8 (10.85)	48.1 (10.26)
Week 24	Number Analyzed	375 participants	190 participants	187 participants	371 participants
		50.1 (9.61)	50.1 (10.34)	49.2 (10.11)	49.4 (10.25)
Week 36	Number Analyzed	348 participants	178 participants	179 participants	327 participants
		51.1 (9.38)	50.6 (10.26)	49.1 (9.61)	49.9 (10.20)
Week 52	Number Analyzed	333 participants	169 participants	172 participants	307 participants
		50.9 (9.32)	50.0 (10.08)	49.7 (10.00)	50.2 (9.64)

30. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	414 participants	207 participants	208 participants	416 participants
		44.6 (10.60)	43.2 (11.47)	43.1 (11.27)	43.5 (11.50)
Change at Week 4	Number Analyzed	406 participants	203 participants	203 participants	411 participants
		4.1 (9.32)	3.6 (8.93)	4.5 (9.59)	1.9 (9.22)
Change at Week 12	Number Analyzed	392 participants	198 participants	193 participants	389 participants
		5.3 (10.00)	5.7 (10.04)	5.5 (10.87)	4.5 (10.26)
Change at Week 24	Number Analyzed	373 participants	190 participants	185 participants	371 participants
		5.4 (10.45)	6.6 (10.89)	5.8 (11.26)	6.0 (10.95)
Change at Week 36	Number Analyzed	346 participants	178 participants	177 participants	327 participants
		6.5 (10.68)	7.3 (11.17)	5.4 (11.66)	6.2 (10.96)
Change at Week 52	Number Analyzed	331 participants	169 participants	170 participants	307 participants
		6.2 (10.74)	6.8 (11.47)	6.1 (11.26)	6.5 (11.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 1.6 to 3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.57
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.032
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 0.1 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.0 to 3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 0.2 to 2.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.60
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.065
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.1 to 2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.74
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.15
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.74
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.73
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.37
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.8 to 2.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.83
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -1.7 to 1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.073
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.1 to 2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.090
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -0.2 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.80
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.68
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -1.9 to 1.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.30
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.6 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.67
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.69
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -1.3 to 1.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.95
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -1.7 to 1.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.82
	Estimation Comments	[Not Specified]

31. Secondary Outcome

Title	FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52
Description	FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	404 participants	201 participants	200 participants	408 participants
		35.2 (9.82)	34.1 (10.75)	34.2 (10.52)	31.4 (10.87)
Week 12	Number Analyzed	386 participants	195 participants	190 participants	386 participants
		38.1 (10.21)	36.6 (11.26)	36.9 (11.16)	35.3 (10.23)
Week 24	Number Analyzed	368 participants	189 participants	183 participants	366 participants
		39.1 (10.13)	38.7 (10.11)	37.9 (10.76)	37.3 (10.62)
Week 36	Number Analyzed	345 participants	177 participants	177 participants	324 participants
		39.8 (9.58)	38.9 (10.19)	38.8 (10.17)	38.1 (9.86)
Week 52	Number Analyzed	322 participants	166 participants	168 participants	300 participants
		40.2 (9.36)	38.7 (9.88)	39.7 (10.96)	38.4 (9.91)

32. Secondary Outcome

Title	Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52
Description	FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Weeks 4, 12, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	411 participants	207 participants	206 participants	415 participants
		28.3 (10.93)	27.3 (11.92)	27.3 (10.90)	27.1 (10.72)
Change at Week 4	Number Analyzed	403 participants	201 participants	198 participants	408 participants
		7.0 (9.46)	6.7 (9.64)	6.8 (9.94)	4.3 (9.24)
Change at Week 12	Number Analyzed	383 participants	195 participants	188 participants	385 participants
		9.8 (11.20)	9.2 (11.21)	9.4 (10.57)	8.1 (10.09)
Change at Week 36	Number Analyzed	343 participants	177 participants	174 participants	323 participants
		11.3 (11.21)	11.9 (11.53)	10.9 (10.81)	11.1 (10.91)
Change at Week 52	Number Analyzed	320 participants	166 participants	166 participants	300 participants
		11.7 (11.52)	11.9 (12.29)	11.5 (11.17)	11.3 (11.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95%; 2.1 to 4.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.58
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; 1.1 to 3.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 1.3 to 4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; 1.0 to 3.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.13
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.4 to 2.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.032
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.1 to 3.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.79
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.028
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 0.2 to 2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.67
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.15
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.4 to 2.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.41
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.9 to 2.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.017
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.3 to 3.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.27
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -0.7 to 2.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.86
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.15
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.87
	Estimation Comments	[Not Specified]

33. Secondary Outcome

Title	Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52
Description	The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Measure Type: Count of Participants; Unit of Measure: Participants
Mobility: Week 4	Number Analyzed	406 participants	202 participants	201 participants	410 participants
	No Problems	161	66	81	104
	Slight Problems	149	68	56	135
	Moderate Problems	82	50	38	116
	Severe Problems	13	17	20	54
	Extreme Problems	1	1	6	1
Mobility: Week 12	Number Analyzed	390 participants	196 participants	192 participants	388 participants
	No Problems	198	87	86	138
	Slight Problems	135	56	60	135
	Moderate Problems	41	36	27	91
	Severe Problems	12	17	14	20
	Extreme Problems	4	0	5	4
Mobility: Week 24	Number Analyzed	377 participants	192 participants	184 participants	370 participants
	No Problems	208	92	95	152
	Slight Problems	116	55	50	135
	Moderate Problems	46	36	24	63
	Severe Problems	5	9	13	16
	Extreme Problems	2	0	2	4
Mobility: Week 36	Number Analyzed	365 participants	188 participants	180 participants	356 participants
	No Problems	216	93	98	152
	Slight Problems	96	60	46	135
	Moderate Problems	48	30	27	51
	Severe Problems	5	5	8	16
	Extreme Problems	0	0	1	2
Mobility: Week 52	Number Analyzed	347 participants	176 participants	174 participants	334 participants
	No Problems	217	91	93	156
	Slight Problems	92	50	47	108
	Moderate Problems	28	29	21	54
	Severe Problems	9	6	10	15
	Extreme Problems	1	0	3	1
Self-Care: Week 4	Number Analyzed	406 participants	202 participants	201 participants	410 participants
	No Problems	214	99	102	143
	Slight Problems	142	63	50	141
	Moderate Problems	42	28	38	96
	Severe Problems	7	9	10	29
	Extreme Problems	1	3	1	1
Self-Care: Week 12	Number Analyzed	390 participants	196 participants	192 participants	388 participants
	No Problems	277	113	111	190
	Slight Problems	85	55	55	129
	Moderate Problems	19	22	21	54
	Severe Problems	6	5	4	13
	Extreme Problems	3	1	1	2
Self-Care: Week 24	Number Analyzed	377 participants	192 participants	184 participants	370 participants
	No Problems	283	128	112	222
	Slight Problems	73	42	52	95
	Moderate Problems	16	20	17	46
	Severe Problems	1	2	3	5
	Extreme Problems	4	0	0	2
Self-Care: Week 36	Number Analyzed	365 participants	188 participants	180 participants	356 participants
	No Problems	271	122	121	224
	Slight Problems	70	44	41	93
	Moderate Problems	20	21	16	31
	Severe Problems	3	1	1	5
	Extreme Problems	1	0	1	3
Self-Care: Week 52	Number Analyzed	347 participants	176 participants	174 participants	334 participants
	No Problems	268	117	117	208
	Slight Problems	60	36	36	84
	Moderate Problems	13	21	16	35
	Severe Problems	5	2	4	6
	Extreme Problems	1	0	1	1
Usual Activities: Week 4	Number Analyzed	406 participants	202 participants	201 participants	410 participants
	No Problems	118	50	54	80
	Slight Problems	180	86	81	153
	Moderate Problems	90	47	49	122
	Severe Problems	16	19	14	49
	Extreme Problems	2	0	3	6
Usual Activities: Week 12	Number Analyzed	390 participants	196 participants	192 participants	388 participants
	No Problems	185	78	83	101
	Slight Problems	148	65	61	179
	Moderate Problems	44	42	35	85
	Severe Problems	11	9	11	19
	Extreme Problems	2	2	2	4
Usual Activities: Week 24	Number Analyzed	377 participants	192 participants	184 participants	370 participants
	No Problems	188	92	83	142
	Slight Problems	135	60	63	147
	Moderate Problems	43	31	30	64
	Severe Problems	8	9	8	13
	Extreme Problems	3	0	0	4
Usual Activities: Week 36	Number Analyzed	365 participants	188 participants	180 participants	356 participants
	No Problems	199	86	92	158
	Slight Problems	119	61	51	134
	Moderate Problems	42	37	31	50
	Severe Problems	5	4	3	12
	Extreme Problems	0	0	3	2
Usual Activities: Week 52	Number Analyzed	347 participants	176 participants	174 participants	334 participants
	No Problems	203	84	92	147
	Slight Problems	106	62	48	125
	Moderate Problems	31	22	27	50
	Severe Problems	7	7	5	10
	Extreme Problems	0	1	2	2
Pain/Discomfort: Week 4	Number Analyzed	406 participants	202 participants	201 participants	410 participants
	No Problems	45	23	21	18
	Slight Problems	208	85	91	131
	Moderate Problems	132	73	60	173
	Severe Problems	21	19	26	78
	Extreme Problems	0	2	3	10
Pain/Discomfort: Week 12	Number Analyzed	390 participants	196 participants	192 participants	388 participants
	No Problems	93	35	38	41
	Slight Problems	202	96	81	167
	Moderate Problems	83	47	53	143
	Severe Problems	12	15	16	35
	Extreme Problems	0	3	4	2
Pain/Discomfort: Week 24	Number Analyzed	377 participants	192 participants	184 participants	370 participants
	No Problems	110	46	40	44
	Slight Problems	182	91	93	206
	Moderate Problems	75	46	42	98
	Severe Problems	9	9	7	22
	Extreme Problems	1	0	2	0
Pain/Discomfort: Week 36	Number Analyzed	365 participants	188 participants	180 participants	356 participants
	No Problems	102	43	39	57
	Slight Problems	188	90	87	195
	Moderate Problems	68	41	44	85
	Severe Problems	6	14	7	18
	Extreme Problems	1	0	3	1
Pain/Discomfort: Week 52	Number Analyzed	347 participants	176 participants	174 participants	334 participants
	No Problems	108	46	49	63
	Slight Problems	169	82	88	168
	Moderate Problems	59	40	25	80
	Severe Problems	11	8	9	22
	Extreme Problems	0	0	3	1
Anxiety/Depression: Week 4	Number Analyzed	406 participants	202 participants	201 participants	410 participants
	No Problems	221	101	94	159
	Slight Problems	126	58	64	148
	Moderate Problems	53	33	35	73
	Severe Problems	6	10	6	25
	Extreme Problems	0	0	2	5
Anxiety/Depression: Week 12	Number Analyzed	390 participants	196 participants	192 participants	388 participants
	No Problems	233	104	106	198
	Slight Problems	114	62	58	125
	Moderate Problems	28	19	17	49
	Severe Problems	14	9	10	15
	Extreme Problems	1	2	1	1
Anxiety/Depression: Week 24	Number Analyzed	377 participants	192 participants	184 participants	370 participants
	No Problems	236	117	103	219
	Slight Problems	97	47	64	93
	Moderate Problems	32	25	11	42
	Severe Problems	9	3	6	14
	Extreme Problems	3	0	0	2
Anxiety/Depression: Week 36	Number Analyzed	365 participants	188 participants	180 participants	356 participants
	No Problems	233	119	103	194
	Slight Problems	99	50	56	116
	Moderate Problems	31	13	17	32
	Severe Problems	2	5	3	12
	Extreme Problems	0	1	1	2
Anxiety/Depression: Week 52	Number Analyzed	347 participants	176 participants	174 participants	334 participants
	No Problems	222	113	106	182
	Slight Problems	94	40	43	100
	Moderate Problems	26	18	20	45
	Severe Problems	5	5	3	5
	Extreme Problems	0	0	2	2

34. Secondary Outcome

Title	EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Description	EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	404 participants	201 participants	200 participants	408 participants
		65 (18.7)	61 (21.6)	62 (20.0)	56 (21.2)
Week 12	Number Analyzed	386 participants	195 participants	190 participants	386 participants
		69 (21.3)	67 (22.9)	66 (22.7)	64 (20.7)
Week 24	Number Analyzed	368 participants	189 participants	183 participants	366 participants
		73 (21.0)	72 (19.6)	68 (22.4)	69 (21.3)
Week 36	Number Analyzed	344 participants	177 participants	177 participants	324 participants
		73 (22.1)	71 (21.8)	69 (21.1)	68 (22.8)
Week 52	Number Analyzed	322 participants	166 participants	168 participants	300 participants
		75 (21.7)	72 (22.1)	71 (23.7)	71 (21.2)

35. Secondary Outcome

Title	Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Description	The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	411 participants	207 participants	206 participants	415 participants
		50 (22.0)	50 (24.6)	51 (22.5)	50 (22.1)
Change at Week 4	Number Analyzed	403 participants	201 participants	198 participants	408 participants
		16 (25.0)	10 (24.6)	11 (22.4)	7 (25.0)
Change at Week 12	Number Analyzed	383 participants	195 participants	188 participants	385 participants
		19 (29.8)	17 (28.0)	15 (26.1)	14 (27.7)
Change at Week 24	Number Analyzed	365 participants	189 participants	181 participants	365 participants
		24 (28.1)	21 (27.7)	17 (29.0)	19 (28.8)
Change at Week 36	Number Analyzed	342 participants	177 participants	174 participants	323 participants
		23 (29.7)	21 (28.6)	18 (28.8)	19 (29.8)
Change at Week 52	Number Analyzed	320 participants	166 participants	166 participants	300 participants
		26 (31.1)	22 (31.5)	20 (30.1)	22 (30.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	9.0
	Confidence Interval	(2-Sided) 95%; 6.0 to 12.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	6.0
	Confidence Interval	(2-Sided) 95%; 3.0 to 9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; 2.0 to 8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.089
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -0.0 to 7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.049
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	4.0
	Confidence Interval	(2-Sided) 95%; 0.0 to 7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.84
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95%; -4.0 to 3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	6.0
	Confidence Interval	(2-Sided) 95%; 2.0 to 9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.078
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -0.0 to 7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg Monotherapy, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.39
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -2.0 to 6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; 2.0 to 8.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.45
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to 6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg + MTX, MTX Monotherapy
	Comments	Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.85
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -4.0 to 5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.1
	Estimation Comments	[Not Specified]

36. Secondary Outcome

Title	Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Week 4	Number Analyzed	167 participants	77 participants	87 participants	150 participants
		10.1 (23.95)	15.4 (30.46)	9.2 (21.88)	16.0 (30.49)
Week 12	Number Analyzed	163 participants	72 participants	84 participants	161 participants
		6.7 (19.11)	7.3 (18.29)	12.6 (24.42)	11.3 (25.59)
Week 24	Number Analyzed	164 participants	72 participants	86 participants	145 participants
		6.4 (19.93)	5.7 (13.96)	12.4 (23.14)	5.1 (14.21)
Week 36	Number Analyzed	156 participants	73 participants	85 participants	131 participants
		5.5 (15.78)	7.0 (17.90)	11.5 (25.28)	5.6 (16.90)
Week 52	Number Analyzed	149 participants	69 participants	76 participants	120 participants
		4.6 (14.62)	8.5 (20.70)	9.8 (22.21)	6.4 (19.84)

37. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Week 4	Number Analyzed	160 participants	70 participants	84 participants	137 participants
		29.6 (24.21)	29.4 (27.76)	33.9 (24.10)	45.3 (26.04)
Week 12	Number Analyzed	160 participants	72 participants	81 participants	152 participants
		22.6 (23.43)	23.6 (24.85)	26.0 (24.78)	32.5 (24.31)
Week 24	Number Analyzed	160 participants	72 participants	84 participants	144 participants
		17.9 (18.95)	18.1 (19.40)	23.2 (24.70)	23.3 (21.18)
Week 36	Number Analyzed	155 participants	72 participants	81 participants	129 participants
		15.5 (18.38)	16.3 (20.31)	20.9 (24.04)	22.7 (24.10)
Week 52	Number Analyzed	148 participants	67 participants	74 participants	116 participants
		14.5 (18.08)	19.6 (22.32)	16.5 (23.08)	18.3 (16.95)

38. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of overall work productivity
Week 4	Number Analyzed	160 participants	70 participants	84 participants	137 participants
		32.8 (25.79)	32.3 (29.18)	37.0 (25.87)	48.6 (27.40)
Week 12	Number Analyzed	160 participants	72 participants	81 participants	152 participants
		25.1 (26.42)	26.7 (28.11)	31.4 (28.43)	35.5 (26.13)
Week 24	Number Analyzed	160 participants	72 participants	84 participants	144 participants
		20.2 (22.36)	22.4 (22.92)	29.3 (28.98)	26.2 (23.45)
Week 36	Number Analyzed	155 participants	72 participants	81 participants	129 participants
		18.8 (22.09)	20.9 (23.34)	24.5 (28.11)	25.0 (25.89)
Week 52	Number Analyzed	148 participants	67 participants	74 participants	116 participants
		17.2 (21.61)	22.9 (25.21)	21.2 (27.26)	20.7 (18.67)

39. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Week 4	Number Analyzed	404 participants	201 participants	200 participants	408 participants
		40.4 (25.52)	46.8 (27.82)	45.4 (25.65)	51.6 (24.73)
Week 12	Number Analyzed	386 participants	195 participants	190 participants	386 participants
		30.6 (25.53)	36.1 (26.77)	34.7 (27.29)	41.1 (24.75)
Week 24	Number Analyzed	368 participants	189 participants	183 participants	366 participants
		26.5 (23.32)	29.5 (26.02)	32.3 (26.92)	32.1 (24.44)
Week 36	Number Analyzed	344 participants	177 participants	177 participants	324 participants
		23.5 (22.54)	29.7 (27.03)	29.0 (26.08)	31.8 (25.55)
Week 52	Number Analyzed	322 participants	166 participants	168 participants	300 participants
		22.5 (22.80)	28.2 (26.54)	25.6 (25.19)	28.8 (23.81)

40. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Baseline	Number Analyzed	171 participants	78 participants	88 participants	167 participants
		12.8 (24.29)	20.1 (32.36)	13.5 (26.35)	15.6 (28.79)
Change at Week 4	Number Analyzed	155 participants	70 participants	82 participants	138 participants
		-1.5 (25.68)	-3.3 (24.44)	-4.0 (21.08)	-1.3 (23.73)
Change at Week 12	Number Analyzed	142 participants	67 participants	75 participants	141 participants
		-4.9 (25.11)	-11.0 (32.65)	-2.3 (23.52)	-5.2 (29.01)
Change at Week 24	Number Analyzed	141 participants	63 participants	77 participants	122 participants
		-4.8 (28.91)	-15.5 (34.51)	-3.1 (28.77)	-10.6 (29.08)
Change at Week 36	Number Analyzed	130 participants	62 participants	69 participants	107 participants
		-6.7 (28.20)	-16.4 (35.63)	-4.1 (26.83)	-7.9 (29.99)
Change at Week 52	Number Analyzed	124 participants	59 participants	65 participants	97 participants
		-4.8 (23.27)	-15.7 (32.72)	-2.8 (29.12)	-6.7 (31.63)

41. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Baseline	Number Analyzed	163 participants	70 participants	82 participants	154 participants
		47.3 (26.32)	49.0 (28.45)	52.1 (25.81)	53.6 (27.12)
Change at Week 4	Number Analyzed	144 participants	62 participants	77 participants	125 participants
		-17.8 (25.34)	-19.8 (27.49)	-18.3 (28.58)	-7.4 (20.55)
Change at Week 12	Number Analyzed	135 participants	61 participants	70 participants	126 participants
		-25.6 (27.09)	-28.4 (29.39)	-26.0 (24.70)	-20.7 (27.83)
Change at Week 24	Number Analyzed	132 participants	56 participants	72 participants	113 participants
		-27.1 (26.77)	-32.9 (28.20)	-27.9 (27.06)	-28.3 (29.06)
Change at Week 36	Number Analyzed	123 participants	55 participants	64 participants	99 participants
		-29.1 (24.99)	-33.8 (27.99)	-30.3 (29.38)	-28.8 (31.92)
Change at Week 52	Number Analyzed	120 participants	51 participants	61 participants	89 participants
		-32.3 (26.81)	-32.7 (31.75)	-33.3 (29.25)	-31.5 (28.23)

42. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of overall work productivity
Baseline	Number Analyzed	163 participants	70 participants	82 participants	154 participants
		50.8 (27.28)	51.6 (30.10)	54.4 (25.60)	56.1 (28.00)
Change at Week 4	Number Analyzed	144 participants	62 participants	77 participants	125 participants
		-17.6 (26.21)	-19.0 (29.43)	-17.6 (28.69)	-6.4 (22.27)
Change at Week 12	Number Analyzed	135 participants	61 participants	70 participants	126 participants
		-26.3 (28.85)	-27.5 (30.53)	-23.5 (26.01)	-20.1 (28.63)
Change at Week 24	Number Analyzed	132 participants	56 participants	72 participants	113 participants
		-28.5 (27.71)	-31.3 (30.04)	-24.7 (29.61)	-27.9 (29.31)
Change at Week 36	Number Analyzed	123 participants	55 participants	64 participants	99 participants
		-29.3 (26.76)	-33.1 (31.56)	-29.1 (31.79)	-29.2 (32.72)
Change at Week 52	Number Analyzed	120 participants	51 participants	61 participants	89 participants
		-33.0 (28.74)	-33.5 (32.34)	-30.6 (31.24)	-30.8 (28.76)

43. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, 24, 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title		Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description:		Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed		416	207	210	416
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Baseline	Number Analyzed	411 participants	207 participants	206 participants	415 participants
		60.2 (23.36)	62.8 (23.10)	63.3 (24.37)	64.0 (22.59)
Change at Week 4	Number Analyzed	403 participants	201 participants	198 participants	408 participants
		-19.9 (24.07)	-15.8 (23.90)	-17.8 (27.11)	-12.4 (23.80)
Change at Week 12	Number Analyzed	383 participants	195 participants	188 participants	385 participants
		-29.4 (27.15)	-26.4 (26.19)	-28.7 (27.80)	-22.7 (25.32)
Change at Week 24	Number Analyzed	365 participants	189 participants	181 participants	365 participants
		-33.1 (26.84)	-33.2 (26.97)	-31.2 (28.01)	-31.5 (27.80)
Change at Week 36	Number Analyzed	342 participants	177 participants	174 participants	323 participants
		-35.6 (26.52)	-33.8 (26.48)	-34.1 (28.26)	-32.1 (28.47)
Change at Week 52	Number Analyzed	320 participants	166 participants	166 participants	300 participants
		-36.7 (27.11)	-35.4 (28.32)	-36.7 (28.37)	-34.2 (28.83)

Adverse Events

Time Frame	First dose date up to last dose date (Maximum: 56 weeks) plus 30 days
Adverse Event Reporting Description	The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Arm/Group Description	Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
All-Cause Mortality
	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/416 (0.72%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Serious Adverse Events
	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	26/416 (6.25%)	13/207 (6.28%)	17/210 (8.10%)	28/416 (6.73%)
Blood and lymphatic system disorders
Bone marrow failure † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Leukocytosis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Pancytopenia † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Thrombocytosis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Cardiac disorders
Acute myocardial infarction † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Atrial fibrillation † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	1/416 (0.24%)
Lupus myocarditis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Myocardial infarction † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Supraventricular tachycardia † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Congenital, familial and genetic disorders
Atrial septal defect † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Endocrine disorders
Hyperthyroidism † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Gastrointestinal disorders
Abdominal pain upper † 1	2/416 (0.48%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Appendiceal mucocoele † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Diverticular perforation † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Gastritis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Gastrointestinal fistula † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Gastrointestinal haemorrhage † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Megacolon † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Proctitis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Small intestinal obstruction † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Upper gastrointestinal haemorrhage † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
General disorders
Chest pain † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Pyrexia † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Systemic inflammatory response syndrome † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Infections and infestations
Abdominal hernia infection † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Appendicitis † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Arthritis infective † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Bronchitis † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	1/416 (0.24%)
Herpes zoster † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Lower respiratory tract infection † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Lymphangitis † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Pneumocystis jirovecii pneumonia † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Pneumonia † 1	4/416 (0.96%)	1/207 (0.48%)	0/210 (0.00%)	1/416 (0.24%)
Pneumonia bacterial † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Pneumonia cryptococcal † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Pulmonary sepsis † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Pyelonephritis † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Pyonephrosis † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Sepsis † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	1/416 (0.24%)
Septic shock † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Skin infection † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Tracheobronchitis † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Injury, poisoning and procedural complications
Accidental overdose † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Femur fracture † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Incisional hernia, obstructive † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Subdural haematoma † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Investigations
White blood cell count decreased † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Hypertriglyceridaemia † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Hypoglycaemia † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Back pain † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Intervertebral disc disorder † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Intervertebral disc protrusion † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Osteoarthritis † 1	0/416 (0.00%)	2/207 (0.97%)	1/210 (0.48%)	1/416 (0.24%)
Pathological fracture † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Spinal osteoarthritis † 1	0/416 (0.00%)	2/207 (0.97%)	1/210 (0.48%)	0/416 (0.00%)
Spinal stenosis † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Giant cell tumour of tendon sheath † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Ovarian adenoma † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Prostate cancer † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Small cell lung cancer † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Squamous cell carcinoma † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Nervous system disorders
Cerebral amyloid angiopathy † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Cerebral artery occlusion † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Cervical radiculopathy † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Facial paralysis † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Haemorrhagic stroke † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Intracranial aneurysm † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Ischaemic stroke † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Subarachnoid haemorrhage † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Vertebral artery aneurysm † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Psychiatric disorders
Depression † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Renal and urinary disorders
Nephrolithiasis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	0/416 (0.00%)	1/207 (0.48%)	0/210 (0.00%)	0/416 (0.00%)
Bronchiectasis † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Emphysema † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Interstitial lung disease † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Lung consolidation † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Pleurisy † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Pneumonitis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Pulmonary embolism † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	2/416 (0.48%)
Skin and subcutaneous tissue disorders
Prurigo † 1	0/416 (0.00%)	0/207 (0.00%)	1/210 (0.48%)	0/416 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
Hypertension † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Rheumatoid vasculitis † 1	1/416 (0.24%)	0/207 (0.00%)	0/210 (0.00%)	0/416 (0.00%)
Varicose vein † 1	0/416 (0.00%)	0/207 (0.00%)	0/210 (0.00%)	1/416 (0.24%)
1 Term from vocabulary, MedDRA (22.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	179/416 (43.03%)	88/207 (42.51%)	78/210 (37.14%)	164/416 (39.42%)
Gastrointestinal disorders
Diarrhoea † 1	17/416 (4.09%)	12/207 (5.80%)	6/210 (2.86%)	21/416 (5.05%)
Nausea † 1	51/416 (12.26%)	35/207 (16.91%)	15/210 (7.14%)	50/416 (12.02%)
Infections and infestations
Bronchitis † 1	12/416 (2.88%)	11/207 (5.31%)	4/210 (1.90%)	15/416 (3.61%)
Nasopharyngitis † 1	21/416 (5.05%)	17/207 (8.21%)	17/210 (8.10%)	25/416 (6.01%)
Upper respiratory tract infection † 1	42/416 (10.10%)	9/207 (4.35%)	14/210 (6.67%)	34/416 (8.17%)
Urinary tract infection † 1	19/416 (4.57%)	13/207 (6.28%)	11/210 (5.24%)	11/416 (2.64%)
Investigations
Alanine aminotransferase increased † 1	23/416 (5.53%)	6/207 (2.90%)	3/210 (1.43%)	11/416 (2.64%)
Nervous system disorders
Headache † 1	23/416 (5.53%)	8/207 (3.86%)	8/210 (3.81%)	25/416 (6.01%)
Skin and subcutaneous tissue disorders
Alopecia † 1	17/416 (4.09%)	15/207 (7.25%)	4/210 (1.90%)	20/416 (4.81%)
Vascular disorders
Hypertension † 1	21/416 (5.05%)	10/207 (4.83%)	15/210 (7.14%)	14/416 (3.37%)
1 Term from vocabulary, MedDRA (22.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

• The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
• The study has been completed at all study sites for at least 2 years

Results Point of Contact

• Name/Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences
• Phone: 1-833-445-3230 (GILEAD-0)
• EMail: GileadClinicalTrials@gilead.com

Publications of Results:

Westhovens R, Rigby W, van der Heijde D, Ching D, Bartok B, Matzkies F, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis naive to methotrexate therapy: FINCH 3 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2): A259.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tanaka Y, Atsumi T, Aletaha D, Bartok B, Pechonkina A, Han L, Emoto K, Kano S, Rajendran V, Takeuchi T. Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials. Rheumatol Ther. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 2022 Nov 3.

Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.

Aletaha D, Westhovens R, Gaujoux-Viala C, Adami G, Matsumoto A, Bird P, Messina OD, Buch MH, Bartok B, Yin Z, Guo Y, Hendrikx T, Burmester GR. Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3. RMD Open. 2021 Aug;7(2):e001621. doi: 10.1136/rmdopen-2021-001621.

Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy JS, Jahreis A, Mozaffarian N, Messina OD, Landewe RB, Atsumi T, Burmester GR. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021 Jun;80(6):727-738. doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02886728
• Other Study ID Numbers: GS-US-417-0303; 2016-000570-37 ( EudraCT Number )
• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Results First Submitted: December 21, 2020
• Results First Posted: January 15, 2021
• Last Update Posted: June 1, 2021