Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)

• ClinicalTrials.gov Identifier: NCT02889796
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Results First Posted: January 19, 2021
• Last Update Posted: June 9, 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: Adalimumab; Drug: Placebo to match adalimumab; Drug: MTX
• Enrollment: 1759

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019.
Pre-assignment Details	2582 participants were screened.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo Never Received Filgotinib
Arm/Group Description	Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.
Period Title: Overall Study
Started	477	480	325	190	191	96
Completed	424	422	281	181	185	24 [1]
Not Completed	53	58	44	9	6	72
Reason Not Completed
Withdrew Consent	18	29	20	1	2	35
Investigator's Discretion	10	9	10	3	0	15
Adverse Event	17	8	8	4	1	7
Lost to Follow-up	5	7	2	0	2	6
Protocol Violation	0	1	3	0	0	4
Non-compliance With Study Drug	0	2	0	0	1	2
Death	1	1	0	1	0	1
Pregnancy	0	1	1	0	0	0
Randomized but not Dosed	2	0	0	0	0	2
[1] Completed 24 weeks of placebo treatment and not rerandomized to Filgotinib 200 mg or 100 mg groups

Baseline Characteristics

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo	Total
Arm/Group Description		Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Total of all reporting groups
Overall Number of Baseline Participants		475	480	325	475	1755
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	475 participants	480 participants	325 participants	475 participants	1755 participants
		52 (12.8)	53 (12.6)	53 (12.9)	53 (12.8)	53 (12.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	475 participants	480 participants	325 participants	475 participants	1755 participants
	Female	379	399	266	391	1435
	Male	96	81	59	84	320
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	475 participants	480 participants	325 participants	475 participants	1755 participants
	American Indian or Alaska Native	27	27	20	29	103
	Asian: Japanese	40	41	28	38	147
	Asian: Chinese/Taiwanese/Hong Kong Chinese	13	12	8	18	51
	Asian: Korean	13	10	4	7	34
	Asian: Other	56	52	25	46	179
	Black or African American	6	7	10	12	35
	Native Hawaiian or Pacific Islander	1	0	0	2	3
	White	312	324	229	319	1184
	Other	7	6	1	3	17
	Not Permitted	0	1	0	1	2
		[1] Measure Description: Not Permitted=local regulators did not allow collection of race information.
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	475 participants	480 participants	325 participants	475 participants	1755 participants
	Hispanic or Latino	67	71	54	70	262
	Not Hispanic or Latino	404	399	268	400	1471
	Not Permitted	4	10	3	5	22
		[1] Measure Description: Not Permitted=local regulators did not allow collection of ethnicity information.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	475 participants	480 participants	325 participants	475 participants	1755 participants
United States		47	55	37	60	199
South Africa		12	11	3	8	34
South Korea		12	10	4	7	33
Spain		14	3	6	7	30
Germany		5	6	5	4	20
New Zealand		5	5	3	5	18
United Kingdom		1	2	4	6	13
Canada		4	4	3	1	12
Israel		4	1	2	4	11
Belgium		2	3	4	1	10
Italy		2	1	2	1	6
Netherlands		0	1	0	1	2
Australia		0	1	0	0	1
Ireland		0	1	0	0	1
Poland		78	82	64	74	298
Ukraine		66	73	41	55	235
India		40	39	19	39	137
Russia		34	32	22	30	118
Hungary		12	12	5	17	46
Bulgaria		7	7	6	14	34
Czechia		7	7	7	13	34
Romania		12	6	2	11	31
Serbia		1	7	8	5	21
Slovakia		2	2	1	3	8
Mexico		33	33	25	34	125
Argentina		15	17	10	15	57
Taiwan		12	9	7	16	44
Thailand		7	6	6	4	23
Hong Kong		1	3	1	2	7
Japan		40	41	28	38	147

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
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)participant'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 12

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	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	76.6; (72.7 to 80.5)	69.8; (65.6 to 74.0)	70.5; (65.3 to 75.6)	49.9; (45.3 to 54.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	26.7
	Confidence Interval	(2-Sided) 95%; 20.6 to 32.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	19.9
	Confidence Interval	(2-Sided) 95%; 13.6 to 26.2
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
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). 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 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.63 (0.613)
Change from Baseline at Week 12	Number Analyzed	457 participants	459 participants	311 participants	435 participants
		-0.69 (0.613)	-0.56 (0.564)	-0.61 (0.560)	-0.42 (0.544)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. 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	Mixed effects model for repeated measure
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.034
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.17
	Confidence Interval	(2-Sided) 95%; -0.24 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.034
	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 12
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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) 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 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	34.1; (29.7 to 38.5)	23.8; (19.8 to 27.7)	23.7; (18.9 to 28.5)	9.3; (6.6 to 12.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 19.6 to 30.0
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	14.5
	Confidence Interval	(2-Sided) 95%; 9.7 to 19.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 using non-responder imputation (NRI).
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 using NRI.
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab 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	10.4
	Confidence Interval	(2-Sided) 95%; 3.9 to 17.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.99
	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	0.1
	Confidence Interval	(2-Sided) 95%; -6.2 to 6.3
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in 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, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal 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	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		467	471	319	466
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	467 participants	471 participants	319 participants	466 participants
		32.47 (47.939)	36.70 (53.065)	34.82 (55.013)	31.60 (53.217)
Change from Baseline at Week 24	Number Analyzed	405 participants	404 participants	271 participants	351 participants
		0.13 (0.937)	0.17 (0.905)	0.16 (0.948)	0.37 (1.417)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-0.27
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.078
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.25
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.078
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12
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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	49.7; (45.1 to 54.3)	38.8; (34.3 to 43.2)	43.4; (37.8 to 48.9)	23.4; (19.5 to 27.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	26.3
	Confidence Interval	(2-Sided) 95%; 20.2 to 32.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	15.4
	Confidence Interval	(2-Sided) 95%; 9.4 to 21.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
Statistical Test of Hypothesis	P-Value	0.054
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.069
	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%; -1.0 to 13.6
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12
	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	-4.6
	Confidence Interval	(2-Sided) 95%; -11.8 to 2.6
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
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 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		473	479	323	474
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	474 participants
		33.4 (7.17)	33.6 (7.75)	32.8 (7.74)	32.9 (7.11)
Change from Baseline at Week 12	Number Analyzed	459 participants	463 participants	310 participants	440 participants
		9.2 (8.10)	8.5 (7.72)	8.4 (7.89)	5.8 (7.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 2.8 to 4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	3.1
	Confidence Interval	(2-Sided) 95%; 2.2 to 4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.46
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		472	477	319	469
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	469 participants
		27.6 (10.68)	27.8 (10.60)	27.2 (10.20)	26.9 (10.34)
Change from Baseline at Week 12	Number Analyzed	452 participants	455 participants	304 participants	432 participants
		9.2 (9.82)	9.1 (10.15)	8.8 (9.19)	6.8 (9.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	2.8
	Confidence Interval	(2-Sided) 95%; 1.7 to 3.9
	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, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	2.6
	Confidence Interval	(2-Sided) 95%; 1.5 to 3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	9.1; (6.4 to 11.7)	5.8; (3.6 to 8.0)	6.8; (3.9 to 9.7)	1.1; (0.0 to 2.1)
Week 4	22.3; (18.5 to 26.2)	12.9; (9.8 to 16.0)	17.2; (13.0 to 21.5)	5.9; (3.7 to 8.1)
Week 12	47.2; (42.6 to 51.8)	36.5; (32.0 to 40.9)	35.1; (29.7 to 40.4)	19.8; (16.1 to 23.5)
Week 24	57.9; (53.3 to 62.4)	52.7; (48.1 to 57.3)	52.3; (46.7 to 57.9)	33.3; (28.9 to 37.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	8.0
	Confidence Interval	(2-Sided) 95%; 5.1 to 10.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	4.8
	Confidence Interval	(2-Sided) 95%; 2.3 to 7.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	16.4
	Confidence Interval	(2-Sided) 95%; 11.9 to 20.9
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	7.0
	Confidence Interval	(2-Sided) 95%; 3.1 to 10.9
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	27.4
	Confidence Interval	(2-Sided) 95%; 21.4 to 33.3
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	16.7
	Confidence Interval	(2-Sided) 95%; 10.9 to 22.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	24.6
	Confidence Interval	(2-Sided) 95%; 18.3 to 31.0
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	19.4
	Confidence Interval	(2-Sided) 95%; 13.1 to 25.8
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR50 at Weeks 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 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	63.2; (58.7 to 67.6)	57.7; (53.2 to 62.2)	57.5; (52.0 to 63.1)	67.9; (61.0 to 74.8)	63.4; (56.3 to 70.4)
Week 52	64.2; (59.8 to 68.6)	60.6; (56.2 to 65.1)	62.2; (56.7 to 67.6)	68.4; (61.5 to 75.3)	66.0; (59.0 to 72.9)

10. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	2.7; (1.2 to 4.3)	1.3; (0.2 to 2.3)	0.9; (0.0 to 2.1)	0.4; (0.0 to 1.1)
Week 4	9.1; (6.4 to 11.7)	3.3; (1.6 to 5.0)	3.7; (1.5 to 5.9)	1.5; (0.3 to 2.7)
Week 12	26.1; (22.1 to 30.2)	18.5; (15.0 to 22.1)	14.2; (10.2 to 18.1)	6.7; (4.4 to 9.1)
Week 24	36.2; (31.8 to 40.6)	29.6; (25.4 to 33.8)	29.5; (24.4 to 34.7)	14.9; (11.6 to 18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2
	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	2.3
	Confidence Interval	(2-Sided) 95%; 0.5 to 4.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2
	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	0.8
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 4.6 to 10.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.067
	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%; -0.3 to 4.0
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	19.4
	Confidence Interval	(2-Sided) 95%; 14.6 to 24.1
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	11.8
	Confidence Interval	(2-Sided) 95%; 7.5 to 16.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	21.3
	Confidence Interval	(2-Sided) 95.0%; 15.7 to 26.9
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	14.6
	Confidence Interval	(2-Sided) 95%; 9.2 to 20.0
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR70 at Weeks 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 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	40.2; (35.7 to 44.7)	35.4; (31.0 to 39.8)	32.9; (27.7 to 38.2)	44.7; (37.4 to 52.1)	34.6; (27.5 to 41.6)
Week 52	44.4; (39.8 to 49.0)	39.0; (34.5 to 43.4)	41.2; (35.7 to 46.7)	48.4; (41.1 to 55.8)	37.7; (30.6 to 44.8)

12. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	37.3; (32.8 to 41.7)	27.5; (23.4 to 31.6)	33.5; (28.3 to 38.8)	14.9; (11.6 to 18.3)
Week 4	51.6; (47.0 to 56.2)	45.6; (41.1 to 50.2)	47.1; (41.5 to 52.7)	31.8; (27.5 to 36.1)
Week 24	78.1; (74.3 to 81.9)	77.7; (73.9 to 81.5)	74.5; (69.6 to 79.4)	59.2; (54.6 to 63.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	22.3
	Confidence Interval	(2-Sided) 95%; 16.7 to 27.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	12.6
	Confidence Interval	(2-Sided) 95%; 7.2 to 17.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	19.8
	Confidence Interval	(2-Sided) 95%; 13.4 to 26.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	13.8
	Confidence Interval	(2-Sided) 95%; 7.5 to 20.2
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	18.9
	Confidence Interval	(2-Sided) 95%; 13.0 to 24.9
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	18.6
	Confidence Interval	(2-Sided) 95%; 12.6 to 24.5
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR20 Response at Weeks 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 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	82.9; (79.5 to 86.4)	79.2; (75.4 to 82.9)	76.3; (71.5 to 81.1)	90.5; (86.1 to 95.0)	86.9; (81.9 to 92.0)
Week 52	82.9; (79.5 to 86.4)	79.6; (75.9 to 83.3)	77.8; (73.2 to 82.5)	86.3; (81.2 to 91.5)	85.9; (80.7 to 91.1)

14. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 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 (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.
Time Frame	Baseline; Weeks 2, 4, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.63 (0.613)
Change from Baseline at Week 2	Number Analyzed	463 participants	474 participants	317 participants	466 participants
		-0.30 (0.443)	-0.22 (0.406)	-0.29 (0.440)	-0.15 (0.357)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-0.43 (0.493)	-0.33 (0.454)	-0.40 (0.460)	-0.26 (0.431)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	376 participants
		-0.82 (0.632)	-0.75 (0.597)	-0.78 (0.632)	-0.62 (0.598)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-0.17
	Confidence Interval	(2-Sided) 95%; -0.22 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.09
	Confidence Interval	(2-Sided) 95%; -0.14 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-0.19
	Confidence Interval	(2-Sided) 95%; -0.24 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.028
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.10
	Confidence Interval	(2-Sided) 95%; -0.15 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.028
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-0.27
	Confidence Interval	(2-Sided) 95%; -0.34 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.037
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.19
	Confidence Interval	(2-Sided) 95%; -0.26 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.037
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 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.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.68 (0.578)	1.58 (0.603)
Change from Baseline at Week 36	Number Analyzed	412 participants	417 participants	275 participants	180 participants	188 participants
		-0.88 (0.633)	-0.80 (0.611)	-0.81 (0.634)	-0.96 (0.637)	-0.69 (0.610)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-0.93 (0.649)	-0.85 (0.621)	-0.85 (0.647)	-0.99 (0.644)	-0.73 (0.650)

16. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: tender joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		25 (13.5)	25 (13.4)	24 (13.2)	24 (13.5)
Change from Baseline at Week 2	Number Analyzed	464 participants	473 participants	317 participants	464 participants
		-8 (10.1)	-7 (9.3)	-7 (8.8)	-5 (9.0)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-11 (11.1)	-10 (10.3)	-9 (9.2)	-8 (10.5)
Change from Baseline at Week 12	Number Analyzed	458 participants	458 participants	311 participants	435 participants
		-17 (11.1)	-15 (10.7)	-15 (9.9)	-13 (11.6)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	375 participants
		-20 (12.1)	-19 (10.9)	-18 (11.1)	-17 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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
	Confidence Interval	(2-Sided) 95%; -4.0 to -2.0
	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, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	0.010
	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	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -5.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-2.0
	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 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -5.0 to -2.0
	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 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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 -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, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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 -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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]

17. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: TJC68 at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: tender joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		25 (13.5)	25 (13.4)	24 (13.2)	25 (12.8)	24 (12.9)
Change from Baseline at Week 36	Number Analyzed	411 participants	417 participants	275 participants	178 participants	188 participants
		-21 (11.9)	-20 (11.2)	-19 (11.0)	-21 (11.4)	-19 (11.5)
Change from Baseline at Week 52	Number Analyzed	400 participants	397 participants	265 participants	173 participants	177 participants
		-21 (12.2)	-21 (11.4)	-20 (11.4)	-21 (11.9)	-20 (11.2)

18. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
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" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) 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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: swollen joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		15 (8.5)	15 (8.5)	16 (8.4)	16 (8.5)
Change from Baseline at Week 2	Number Analyzed	464 participants	473 participants	317 participants	464 participants
		-6 (6.7)	-5 (6.8)	-6 (5.8)	-5 (6.9)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-8 (7.1)	-8 (7.8)	-7 (6.6)	-6 (7.8)
Change from Baseline at Week 12	Number Analyzed	458 participants	458 participants	311 participants	435 participants
		-11 (7.5)	-11 (8.1)	-11 (7.1)	-10 (8.4)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	375 participants
		-13 (7.8)	-13 (7.4)	-13 (6.9)	-12 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	0.047
	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	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-2.0
	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 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-2.0
	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 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-1.0
	Confidence Interval	(2-Sided) 95.0%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: SJC66 at Weeks 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" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: swollen joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		15 (8.5)	15 (8.5)	16 (8.4)	16 (8.2)	15 (7.9)
Change from Baseline at Week 36	Number Analyzed	411 participants	417 participants	275 participants	178 participants	188 participants
		-14 (7.8)	-13 (7.6)	-14 (7.1)	-14 (7.3)	-13 (7.2)
Change from Baseline at Week 52	Number Analyzed	400 participants	397 participants	265 participants	173 participants	177 participants
		-14 (8.1)	-13 (7.6)	-14 (7.5)	-14 (7.8)	-13 (7.4)

20. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		67 (19.2)	65 (19.7)	67 (19.1)	68 (18.7)
Change from Baseline at Week 2	Number Analyzed	464 participants	474 participants	318 participants	466 participants
		-16 (20.1)	-11 (18.4)	-13 (18.1)	-8 (17.2)
Change from Baseline at Week 4	Number Analyzed	469 participants	472 participants	319 participants	461 participants
		-22 (21.5)	-16 (20.8)	-19 (20.8)	-13 (20.2)
Change from Baseline at Week 12	Number Analyzed	457 participants	458 participants	311 participants	435 participants
		-33 (24.8)	-28 (24.7)	-28 (23.2)	-21 (24.8)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	376 participants
		-39 (25.8)	-36 (24.9)	-36 (24.9)	-31 (26.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -11.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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 -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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 -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-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 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-10.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-11.0
	Confidence Interval	(2-Sided) 95%; -14.0 to -7.0
	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, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-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]

21. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: SGA at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		67 (19.2)	65 (19.7)	67 (19.1)	70 (17.8)	66 (18.7)
Change from Baseline at Week 36	Number Analyzed	412 participants	417 participants	274 participants	180 participants	188 participants
		-42 (24.2)	-39 (25.3)	-39 (25.2)	-45 (24.7)	-38 (25.5)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-44 (24.4)	-41 (25.4)	-42 (25.7)	-45 (27.6)	-41 (25.3)

22. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants were rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		66 (16.0)	65 (16.5)	67 (15.5)	66 (16.2)
Change from Baseline at Week 2	Number Analyzed	463 participants	469 participants	315 participants	463 participants
		-20 (19.3)	-18 (18.5)	-19 (17.9)	-13 (17.8)
Change from Baseline at Week 4	Number Analyzed	468 participants	466 participants	318 participants	457 participants
		-28 (21.2)	-26 (19.7)	-26 (19.6)	-20 (19.6)
Change from Baseline at Week 12	Number Analyzed	457 participants	450 participants	308 participants	433 participants
		-41 (20.2)	-39 (20.3)	-39 (20.4)	-34 (22.4)
Change from Baseline at Week 24	Number Analyzed	413 participants	419 participants	283 participants	373 participants
		-48 (19.2)	-46 (19.6)	-47 (19.4)	-42 (20.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -10.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -8.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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 -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -9.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-8.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-7.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-7.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

23. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: PGA at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		66 (16.0)	65 (16.5)	67 (15.5)	68 (15.6)	64 (16.3)
Change from Baseline at Week 36	Number Analyzed	409 participants	416 participants	273 participants	176 participants	187 participants
		-51 (19.0)	-49 (19.8)	-50 (18.6)	-53 (19.5)	-47 (20.0)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-53 (18.2)	-50 (19.2)	-52 (18.9)	-54 (19.7)	-50 (19.3)

24. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		65 (20.4)	64 (20.1)	64 (19.5)	66 (19.0)
Change from Baseline at Week 2	Number Analyzed	463 participants	474 participants	317 participants	466 participants
		-16 (21.0)	-12 (18.7)	-13 (20.4)	-7 (18.2)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	319 participants	461 participants
		-21 (23.7)	-18 (20.9)	-18 (21.9)	-12 (20.8)
Change from Baseline at Week 12	Number Analyzed	457 participants	458 participants	311 participants	435 participants
		-31 (26.9)	-29 (25.3)	-27 (23.6)	-21 (26.0)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	376 participants
		-38 (27.0)	-37 (25.6)	-35 (24.2)	-30 (27.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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 -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -8.0 to -3.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -9.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-10.0
	Confidence Interval	(2-Sided) 95%; -13.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-11.0
	Confidence Interval	(2-Sided) 95%; -14.0 to -7.0
	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, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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 -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		65 (20.4)	64 (20.1)	64 (19.5)	68 (18.0)	65 (19.2)
Change from Baseline at Week 36	Number Analyzed	412 participants	417 participants	274 participants	180 participants	188 participants
		-40 (26.3)	-38 (26.2)	-37 (25.5)	-44 (24.9)	-39 (25.9)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-43 (26.2)	-41 (25.9)	-41 (25.6)	-45 (26.6)	-41 (25.6)

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: mg/L
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		16.13 (21.005)	16.74 (22.982)	14.56 (18.003)	16.25 (24.051)
Change from Baseline at Week 2	Number Analyzed	455 participants	467 participants	315 participants	463 participants
		-10.85 (20.154)	-7.67 (17.888)	-8.03 (15.594)	-0.07 (17.244)
Change from Baseline at Week 4	Number Analyzed	465 participants	468 participants	319 participants	456 participants
		-9.99 (21.146)	-8.44 (20.201)	-7.17 (16.896)	-1.12 (19.940)
Change from Baseline at Week 12	Number Analyzed	456 participants	454 participants	308 participants	431 participants
		-11.00 (18.659)	-9.55 (21.330)	-7.85 (20.632)	-3.26 (22.711)
Change from Baseline at Week 24	Number Analyzed	416 participants	419 participants	281 participants	370 participants
		-11.84 (20.693)	-10.54 (22.215)	-6.17 (24.224)	-4.00 (19.614)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-10.83
	Confidence Interval	(2-Sided) 95%; -12.70 to -8.96
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.952
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-7.73
	Confidence Interval	(2-Sided) 95%; -9.58 to -5.87
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.947
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-9.39
	Confidence Interval	(2-Sided) 95%; -11.33 to -7.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.989
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-7.35
	Confidence Interval	(2-Sided) 95%; -9.29 to -5.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.987
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-8.02
	Confidence Interval	(2-Sided) 95%; -9.90 to -6.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.961
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-6.46
	Confidence Interval	(2-Sided) 95%; -8.35 to -4.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.960
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-7.91
	Confidence Interval	(2-Sided) 95%; -9.88 to -5.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.007
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-6.59
	Confidence Interval	(2-Sided) 95%; -8.56 to -4.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.005
	Estimation Comments	[Not Specified]

27. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
Description	[Not Specified]
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: mg/L
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		16.13 (21.005)	16.74 (22.982)	14.56 (18.003)	16.54 (24.782)	15.76 (21.871)
Change from Baseline at Week 36	Number Analyzed	408 participants	413 participants	273 participants	179 participants	184 participants
		-11.51 (21.990)	-10.72 (22.569)	-8.73 (18.214)	-12.12 (23.151)	-8.50 (19.749)
Change from Baseline at Week 52	Number Analyzed	396 participants	386 participants	259 participants	169 participants	171 participants
		-12.19 (20.773)	-11.27 (23.129)	-9.60 (16.511)	-11.43 (20.873)	-8.74 (19.921)

28. Secondary Outcome

Title	Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 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 (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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	Number Analyzed	459 participants	467 participants	316 participants	463 participants
		52.5; (47.8 to 57.2)	46.7; (42.0 to 51.3)	51.9; (46.2 to 57.6)	40.2; (35.6 to 44.7)
Week 4	Number Analyzed	459 participants	467 participants	316 participants	463 participants
		66.2; (61.8 to 70.7)	58.0; (53.4 to 62.6)	63.9; (58.5 to 69.4)	49.9; (45.2 to 54.6)
Week 12	Number Analyzed	459 participants	467 participants	316 participants	463 participants
		78.9; (75.0 to 82.7)	71.5; (67.3 to 75.7)	72.8; (67.6 to 77.9)	57.9; (53.3 to 62.5)
Week 24	Number Analyzed	459 participants	467 participants	316 participants	463 participants
		76.0; (72.0 to 80.0)	73.4; (69.3 to 77.6)	71.2; (66.1 to 76.4)	59.4; (54.8 to 64.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	12.3
	Confidence Interval	(2-Sided) 95%; 5.7 to 18.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2.
	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	6.5
	Confidence Interval	(2-Sided) 95%; -0.1 to 13.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 9.8 to 22.8
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	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%; 1.5 to 14.7
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	21.0
	Confidence Interval	(2-Sided) 95%; 14.9 to 27.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	13.6
	Confidence Interval	(2-Sided) 95%; 7.3 to 19.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 10.5 to 22.8
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; 7.8 to 20.3
	Estimation Comments	[Not Specified]

29. Secondary Outcome

Title	Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 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 0-3 [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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	Number Analyzed	459 participants	467 participants	316 participants	185 participants	188 participants
		77.1; (73.2 to 81.1)	74.9; (70.9 to 79.0)	71.5; (66.4 to 76.7)	83.2; (77.6 to 88.9)	77.7; (71.4 to 83.9)
Week 52	Number Analyzed	459 participants	467 participants	316 participants	185 participants	188 participants
		75.8; (71.8 to 79.8)	73.0; (68.9 to 77.2)	70.3; (65.1 to 75.5)	81.6; (75.8 to 87.5)	71.8; (65.1 to 78.5)

30. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		5.8 (0.88)	5.7 (0.95)	5.7 (0.88)	5.7 (0.91)
Change from Baseline at Week 2	Number Analyzed	452 participants	464 participants	314 participants	461 participants
		-1.3 (1.05)	-1.0 (0.90)	-1.1 (0.90)	-0.6 (0.79)
Change from Baseline at Week 4	Number Analyzed	463 participants	467 participants	318 participants	454 participants
		-1.7 (1.19)	-1.4 (1.07)	-1.4 (1.04)	-0.9 (0.98)
Change from Baseline at Week 12	Number Analyzed	455 participants	452 participants	308 participants	431 participants
		-2.5 (1.24)	-2.2 (1.17)	-2.2 (1.12)	-1.6 (1.19)
Change from Baseline at Week 24	Number Analyzed	415 participants	419 participants	281 participants	368 participants
		-3.1 (1.17)	-2.8 (1.08)	-2.7 (1.20)	-2.2 (1.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-0.7
	Confidence Interval	(2-Sided) 95%; -0.9 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.4
	Confidence Interval	(2-Sided) 95%; -0.5 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -0.9 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-1.0
	Confidence Interval	(2-Sided) 95%; -1.1 to -0.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -0.8 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-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 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-0.7
	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]

31. Secondary Outcome

Title	Change From Baseline in DAS28 (CRP) at Weeks 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		5.8 (0.88)	5.7 (0.95)	5.7 (0.88)	5.9 (0.89)	5.6 (0.89)
Change from Baseline at Week 36	Number Analyzed	407 participants	413 participants	272 participants	177 participants	184 participants
		-3.2 (1.09)	-2.9 (1.17)	-2.9 (1.16)	-3.3 (1.10)	-2.8 (1.08)
Change from Baseline at Week 52	Number Analyzed	393 participants	385 participants	259 participants	169 participants	171 participants
		-3.4 (1.11)	-3.1 (1.09)	-3.1 (1.13)	-3.3 (1.16)	-3.0 (1.04)

32. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	13.1; (9.9 to 16.2)	8.1; (5.6 to 10.7)	9.8; (6.5 to 13.2)	3.6; (1.8 to 5.4)
Week 4	25.5; (21.5 to 29.5)	20.4; (16.7 to 24.1)	20.9; (16.3 to 25.5)	9.3; (6.6 to 12.0)
Week 24	60.6; (56.1 to 65.1)	53.1; (48.6 to 57.7)	50.5; (44.9 to 56.1)	33.7; (29.3 to 38.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	9.5
	Confidence Interval	(2-Sided) 95%; 5.8 to 13.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	4.5
	Confidence Interval	(2-Sided) 95%; 1.4 to 7.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	16.2
	Confidence Interval	(2-Sided) 95%; 11.3 to 21.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	11.2
	Confidence Interval	(2-Sided) 95%; 6.5 to 15.8
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	26.9
	Confidence Interval	(2-Sided) 95%; 20.6 to 33.3
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	19.4
	Confidence Interval	(2-Sided) 95%; 13.1 to 25.8
	Estimation Comments	[Not Specified]

33. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	67.4; (63.0 to 71.7)	60.2; (55.7 to 64.7)	58.2; (52.6 to 63.7)	74.7; (68.3 to 81.2)	66.5; (59.5 to 73.4)
Week 52	68.2; (63.9 to 72.5)	62.1; (57.6 to 66.5)	61.8; (56.4 to 67.3)	69.5; (62.7 to 76.3)	67.5; (60.6 to 74.4)

34. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	5.1; (3.0 to 7.1)	1.7; (0.4 to 2.9)	3.4; (1.3 to 5.5)	0.6; (0.0 to 1.4)
Week 4	13.7; (10.5 to 16.9)	8.8; (6.1 to 11.4)	8.0; (4.9 to 11.1)	2.9; (1.3 to 4.6)
Week 24	48.4; (43.8 to 53.0)	35.2; (30.8 to 39.6)	35.7; (30.3 to 41.1)	16.2; (12.8 to 19.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	4.4
	Confidence Interval	(2-Sided) 95%; 2.1 to 6.7
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	1.0
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	10.7
	Confidence Interval	(2-Sided) 95%; 7.1 to 14.4
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	5.8
	Confidence Interval	(2-Sided) 95%; 2.6 to 9.0
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	32.2
	Confidence Interval	(2-Sided) 95%; 26.4 to 38.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	19.0
	Confidence Interval	(2-Sided) 95%; 13.4 to 24.6
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab 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	12.7
	Confidence Interval	(2-Sided) 95%; 5.6 to 19.9
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 24.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.88
	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	-0.5
	Confidence Interval	(2-Sided) 95%; -7.5 to 6.5
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 24.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 at using NRI.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 24.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 at using NRI.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

35. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	50.3; (45.7 to 54.9)	42.9; (38.4 to 47.4)	42.5; (36.9 to 48.0)	52.1; (44.7 to 59.5)	46.1; (38.7 to 53.4)
Week 52	54.5; (49.9 to 59.1)	44.8; (40.2 to 49.3)	48.6; (43.0 to 54.2)	50.5; (43.2 to 57.9)	50.8; (43.4 to 58.1)

36. Secondary Outcome

Title	American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
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 hsCRP). 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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: percent improvement
Week 2	Number Analyzed	441 participants	451 participants	306 participants	450 participants
		18.3 (19.98)	14.0 (17.14)	16.3 (18.41)	8.0 (12.82)
Week 4	Number Analyzed	453 participants	453 participants	311 participants	443 participants
		27.4 (25.24)	23.0 (22.26)	23.8 (22.94)	15.1 (18.92)
Week 12	Number Analyzed	445 participants	436 participants	300 participants	422 participants
		46.8 (28.46)	40.6 (27.32)	40.4 (26.18)	28.1 (25.22)
Week 24	Number Analyzed	402 participants	408 participants	276 participants	360 participants
		58.8 (27.76)	55.4 (26.47)	54.3 (28.13)	42.6 (27.73)

37. Secondary Outcome

Title	ACR N Percent Improvement (ACR-N) at Weeks 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 hsCRP). 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: percent improvement
Week 36	Number Analyzed	397 participants	406 participants	267 participants	171 participants	181 participants
		62.5 (26.01)	59.1 (27.47)	58.6 (27.17)	63.2 (24.59)	56.1 (27.30)
Week 52	Number Analyzed	385 participants	379 participants	255 participants	165 participants	170 participants
		66.0 (25.89)	63.1 (26.34)	63.5 (27.03)	63.8 (28.00)	59.7 (26.81)

38. Secondary Outcome

Title	Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	Number Analyzed	452 participants	464 participants	314 participants	461 participants
	Good Response	58 12.8%	32 6.9%	27 8.6%	15 3.3%
	Moderate Response	237 52.4%	213 45.9%	158 50.3%	133 28.9%
	No Response	157 34.7%	219 47.2%	129 41.1%	313 67.9%
Week 4	Number Analyzed	463 participants	467 participants	318 participants	454 participants
	Good Response	117 25.3%	86 18.4%	61 19.2%	37 8.1%
	Moderate Response	231 49.9%	242 51.8%	156 49.1%	189 41.6%
	No Response	115 24.8%	139 29.8%	101 31.8%	228 50.2%
Week 12	Number Analyzed	455 participants	452 participants	308 participants	431 participants
	Good Response	234 51.4%	177 39.2%	138 44.8%	106 24.6%
	Moderate Response	188 41.3%	225 49.8%	138 44.8%	224 52.0%
	No Response	33 7.3%	50 11.1%	32 10.4%	101 23.4%
Week 24	Number Analyzed	415 participants	419 participants	281 participants	368 participants
	Good Response	284 68.4%	250 59.7%	163 58.0%	154 41.8%
	Moderate Response	124 29.9%	156 37.2%	97 34.5%	170 46.2%
	No Response	7 1.7%	13 3.1%	21 7.5%	44 12.0%

39. Secondary Outcome

Title	Number of Participants With EULAR Response at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks..	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Measure Type: Count of Participants; Unit of Measure: Participants
Week 36	Number Analyzed	407 participants	413 participants	272 participants	177 participants	184 participants
	Good Response	306 75.2%	276 66.8%	180 66.2%	139 78.5%	124 67.4%
	Moderate Response	99 24.3%	126 30.5%	84 30.9%	38 21.5%	54 29.3%
	No Response	2 0.5%	11 2.7%	8 2.9%	0 0.0%	6 3.3%
Week 52	Number Analyzed	393 participants	385 participants	259 participants	169 participants	171 participants
	Good Response	308 78.4%	282 73.2%	189 73.0%	129 76.3%	126 73.7%
	Moderate Response	82 20.9%	98 25.5%	66 25.5%	38 22.5%	42 24.6%
	No Response	3 0.8%	5 1.3%	4 1.5%	2 1.2%	3 1.8%

40. Secondary Outcome

Title	Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
Description	CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (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. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		39.5 (11.85)	38.6 (12.23)	39.2 (11.51)	39.6 (11.66)
Change from Baseline at Week 2	Number Analyzed	463 participants	469 participants	315 participants	461 participants
		-12.7 (11.86)	-10.7 (11.17)	-11.7 (10.06)	-8.2 (10.10)
Change from Baseline at Week 4	Number Analyzed	468 participants	466 participants	317 participants	457 participants
		-17.6 (12.66)	-15.6 (12.07)	-15.4 (11.13)	-12.4 (11.79)
Change from Baseline at Week 12	Number Analyzed	456 participants	449 participants	308 participants	433 participants
		-26.0 (12.41)	-23.3 (12.32)	-23.5 (11.43)	-20.3 (13.30)
Change from Baseline at Week 24	Number Analyzed	413 participants	419 participants	283 participants	373 participants
		-30.6 (11.88)	-28.6 (11.57)	-28.4 (11.45)	-26.3 (12.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-4.6
	Confidence Interval	(2-Sided) 95%; -5.9 to -3.2
	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, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -4.3 to -1.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.68
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-5.2
	Confidence Interval	(2-Sided) 95%; -6.6 to -3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.73
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-3.9
	Confidence Interval	(2-Sided) 95%; -5.3 to -2.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.73
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-5.9
	Confidence Interval	(2-Sided) 95%; -7.3 to -4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -5.8 to -3.1
	Parameter Dispersion	Type: Standard Deviation; Value: 0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-5.7
	Confidence Interval	(2-Sided) 95%; -6.9 to -4.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.62
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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: 0.62
	Estimation Comments	[Not Specified]

41. Secondary Outcome

Title	Change From Baseline in CDAI at Weeks 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. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		39.5 (11.85)	38.6 (12.23)	39.2 (11.51)	41.4 (11.03)	37.8 (11.23)
Change from Baseline at Week 36	Number Analyzed	409 participants	416 participants	273 participants	176 participants	187 participants
		-32.1 (11.60)	-29.9 (12.18)	-30.4 (11.21)	-33.8 (11.15)	-29.0 (11.02)
Change from Baseline at Week 52	Number Analyzed	399 participants	397 participants	265 participants	173 participants	177 participants
		-32.9 (11.69)	-30.9 (11.70)	-31.6 (11.44)	-34.0 (11.20)	-30.7 (10.80)

42. Secondary Outcome

Title	Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
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 0 to 86. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		41.2 (12.26)	40.2 (12.79)	40.6 (11.88)	41.2 (12.37)
Change from Baseline at Week 2	Number Analyzed	451 participants	460 participants	312 participants	458 participants
		-14.0 (12.19)	-11.4 (11.41)	-12.5 (10.52)	-8.2 (10.38)
Change from Baseline at Week 4	Number Analyzed	462 participants	462 participants	316 participants	450 participants
		-18.6 (13.08)	-16.4 (12.31)	-16.1 (11.47)	-12.5 (12.18)
Change from Baseline at Week 12	Number Analyzed	454 participants	444 participants	305 participants	429 participants
		-27.1 (12.69)	-24.1 (12.54)	-24.3 (12.03)	-20.6 (13.85)
Change from Baseline at Week 24	Number Analyzed	410 participants	415 participants	281 participants	366 participants
		-31.8 (12.18)	-29.7 (12.01)	-29.0 (12.19)	-26.6 (12.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; -7.1 to -4.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-3.6
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.2
	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, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-6.1
	Confidence Interval	(2-Sided) 95%; -7.6 to -4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-4.5
	Confidence Interval	(2-Sided) 95%; -6.0 to -3.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-6.8
	Confidence Interval	(2-Sided) 95%; -8.2 to -5.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; -6.5 to -3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	-6.5
	Confidence Interval	(2-Sided) 95%; -7.8 to -5.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.65
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	-4.8
	Confidence Interval	(2-Sided) 95%; -6.1 to -3.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.65
	Estimation Comments	[Not Specified]

43. Secondary Outcome

Title	Change From Baseline in SDAI at Weeks 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 0 to 86. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		41.2 (12.26)	40.2 (12.79)	40.6 (11.88)	43.0 (11.81)	39.4 (11.81)
Change from Baseline at Week 36	Number Analyzed	405 participants	412 participants	271 participants	175 participants	183 participants
		-33.3 (11.92)	-31.0 (12.69)	-31.2 (11.73)	-35.1 (11.83)	-29.9 (11.40)
Change from Baseline at Week 52	Number Analyzed	393 participants	385 participants	259 participants	169 participants	171 participants
		-34.1 (12.15)	-32.0 (12.25)	-32.6 (11.99)	-34.9 (11.83)	-31.6 (11.11)

44. Secondary Outcome

Title	Change From Baseline in 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, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		468	472	319	187	188
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	468 participants	472 participants	319 participants	187 participants	188 participants
		32.62 (48.306)	36.24 (52.956)	33.94 (53.803)	26.68 (45.870)	32.38 (55.012)
Change from Baseline at Week 52	Number Analyzed	417 participants	411 participants	273 participants	180 participants	178 participants
		0.21 (1.434)	0.50 (2.098)	0.58 (3.621)	0.63 (2.782)	0.90 (3.152)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo to Filgotinib 200 mg
	Comments	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	-0.39
	Confidence Interval	(2-Sided) 95%; -0.77 to -0.01
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo to Filgotinib 100 mg
	Comments	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 participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.77 to -0.02
	Estimation Comments	[Not Specified]

45. Secondary Outcome

Title	Percentage of Participants With no Radiographic Progression From Baseline at Week 24
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Change in mTSS ≤ 0.5	Number Analyzed	405 participants	404 participants	271 participants	351 participants
		93.8; (91.4 to 96.3)	91.1; (88.2 to 94.0)	91.9; (88.4 to 95.3)	87.2; (83.5 to 90.8)
Change in mTSS ≤ 0	Number Analyzed	405 participants	404 participants	271 participants	351 participants
		87.9; (84.6 to 91.2)	85.9; (82.4 to 89.4)	86.3; (82.1 to 90.6)	80.9; (76.7 to 85.2)
Change in mTSS ≤ SDC (1.36)	Number Analyzed	405 participants	404 participants	271 participants	351 participants
		95.8; (93.7 to 97.9)	95.0; (92.8 to 97.3)	94.5; (91.6 to 97.4)	90.3; (87.1 to 93.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.
	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 non-progression rate
	Estimated Value	6.6
	Confidence Interval	(2-Sided) 95%; 2.2 to 11.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.073
	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 non-progression rate
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; -0.8 to 8.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	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 non-progression rate
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 1.5 to 12.5
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.061
	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 non-progression rate
	Estimated Value	5.0
	Confidence Interval	(2-Sided) 95%; -0.6 to 10.6
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).
	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 non-progression rate
	Estimated Value	5.5
	Confidence Interval	(2-Sided) 95%; 1.6 to 9.4
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.012
	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 non-progression rate
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; 0.7 to 8.8
	Estimation Comments	[Not Specified]

46. Secondary Outcome

Title	Percentage of Participants With no Radiographic Progression From Baseline at Week 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; 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Change in mTSS ≤ 0.5	Number Analyzed	417 participants	411 participants	273 participants	180 participants	178 participants
		92.1; (89.4 to 94.8)	87.1; (83.7 to 90.5)	88.6; (84.7 to 92.6)	83.9; (78.2 to 89.5)	83.7; (78.0 to 89.4)
Change in mTSS ≤ 0	Number Analyzed	417 participants	411 participants	273 participants	180 participants	178 participants
		87.5; (84.2 to 90.8)	81.3; (77.4 to 85.2)	82.4; (77.7 to 87.1)	73.3; (66.6 to 80.1)	77.0; (70.5 to 83.4)
Change in mTSS ≤ SDC (1.83)	Number Analyzed	417 participants	411 participants	273 participants	180 participants	178 participants
		95.0; (92.7 to 97.2)	91.5; (88.7 to 94.3)	94.1; (91.2 to 97.1)	90.0; (85.3 to 94.7)	87.6; (82.5 to 92.8)

47. Secondary Outcome

Title	36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 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.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	471 participants	475 participants	321 participants	465 participants
		39.0 (8.22)	38.2 (8.35)	37.7 (8.07)	36.1 (7.40)
Week 12	Number Analyzed	461 participants	464 participants	312 participants	441 participants
		42.7 (8.30)	42.1 (8.69)	41.3 (8.57)	38.8 (7.83)
Week 24	Number Analyzed	426 participants	427 participants	285 participants	376 participants
		43.9 (8.49)	43.7 (8.64)	43.2 (8.95)	40.7 (8.10)

48. Secondary Outcome

Title	SF-36 PCS Score at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 36	Number Analyzed	413 participants	417 participants	276 participants	181 participants	188 participants
		45.2 (8.28)	44.4 (8.54)	43.8 (8.84)	45.2 (7.99)	43.2 (8.82)
Week 52	Number Analyzed	400 participants	399 participants	267 participants	174 participants	180 participants
		45.6 (8.35)	45.1 (8.57)	45.2 (8.55)	45.1 (8.26)	44.1 (8.88)

49. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 4, and 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; Weeks 4, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		473	479	323	474
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	474 participants
		33.4 (7.17)	33.6 (7.75)	32.8 (7.74)	32.9 (7.11)
Change from Baseline at Week 4	Number Analyzed	469 participants	474 participants	319 participants	464 participants
		5.6 (6.57)	4.6 (6.50)	5.0 (6.65)	3.1 (6.32)
Change from Baseline at Week 24	Number Analyzed	424 participants	426 participants	283 participants	376 participants
		10.4 (8.49)	10.3 (8.64)	10.4 (8.47)	7.7 (7.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 1.9 to 3.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.40
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	1.7
	Confidence Interval	(2-Sided) 95%; 1.0 to 2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.40
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 2.1 to 4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; 2.0 to 4.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.52
	Estimation Comments	[Not Specified]

50. Secondary Outcome

Title	Change From Baseline in SF-36 PCS Score at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		473	479	323	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	190 participants	191 participants
		33.4 (7.17)	33.6 (7.75)	32.8 (7.74)	32.2 (6.96)	33.7 (6.96)
Change from Baseline at Week 36	Number Analyzed	412 participants	416 participants	274 participants	181 participants	188 participants
		11.6 (8.28)	11.0 (8.53)	11.1 (9.07)	12.9 (8.92)	9.5 (8.13)
Change from Baseline at Week 52	Number Analyzed	399 participants	398 participants	265 participants	174 participants	180 participants
		12.0 (8.73)	11.5 (8.74)	12.4 (9.21)	13.0 (9.58)	10.4 (8.05)

51. Secondary Outcome

Title	SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 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.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	471 participants	475 participants	321 participants	465 participants
		47.8 (9.90)	47.9 (9.63)	47.9 (10.04)	45.8 (10.35)
Week 12	Number Analyzed	460 participants	464 participants	312 participants	441 participants
		49.3 (9.14)	49.9 (8.90)	48.9 (10.28)	47.7 (10.16)
Week 24	Number Analyzed	426 participants	427 participants	285 participants	376 participants
		50.0 (8.82)	50.2 (8.93)	49.3 (10.26)	49.2 (9.90)

52. Secondary Outcome

Title	SF-36 MCS Score at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 36	Number Analyzed	413 participants	417 participants	276 participants	181 participants	188 participants
		50.1 (8.96)	51.3 (8.88)	50.7 (9.67)	50.7 (9.04)	50.3 (9.47)
Week 52	Number Analyzed	400 participants	399 participants	267 participants	174 participants	180 participants
		50.6 (9.30)	51.5 (8.99)	50.8 (9.51)	50.8 (8.55)	50.1 (9.21)

53. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 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; Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		473	479	323	474
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	474 participants
		43.9 (10.44)	44.6 (10.44)	44.1 (10.44)	43.4 (11.01)
Change from Baseline at Week 4	Number Analyzed	469 participants	474 participants	319 participants	464 participants
		3.9 (7.96)	3.4 (8.35)	3.7 (7.66)	2.3 (8.72)
Change from Baseline at Week 12	Number Analyzed	458 participants	463 participants	310 participants	440 participants
		5.4 (9.45)	5.4 (8.97)	4.9 (9.69)	4.1 (9.50)
Change from Baseline at Week 24	Number Analyzed	424 participants	426 participants	283 participants	376 participants
		6.1 (9.23)	5.7 (9.57)	5.3 (9.25)	5.6 (10.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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%; 0.9 to 2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	0.002
	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	1.5
	Confidence Interval	(2-Sided) 95%; 0.6 to 2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	0.006
	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	1.5
	Confidence Interval	(2-Sided) 95%; 0.4 to 2.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	1.7
	Confidence Interval	(2-Sided) 95%; 0.7 to 2.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.52
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	0.086
	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%; -0.1 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	0.12
	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	0.9
	Confidence Interval	(2-Sided) 95%; -0.2 to 1.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

54. Secondary Outcome

Title	Change From Baseline in SF-36 MCS Score at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		473	479	323	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	190 participants	191 participants
		43.9 (10.44)	44.6 (10.44)	44.1 (10.44)	43.9 (11.06)	43.4 (11.03)
Change from Baseline at Week 36	Number Analyzed	412 participants	416 participants	274 participants	181 participants	188 participants
		6.2 (10.03)	6.6 (10.46)	6.6 (9.40)	6.9 (12.05)	6.8 (9.84)
Change from Baseline at Week 52	Number Analyzed	399 participants	398 participants	265 participants	174 participants	180 participants
		6.7 (10.53)	6.9 (10.61)	6.7 (9.90)	7.2 (11.31)	6.5 (10.35)

55. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 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 0 to 52.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
		33.9 (10.32)	33.3 (9.76)	32.9 (10.11)	30.9 (10.43)
Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
		36.8 (9.64)	36.7 (9.67)	36.1 (9.68)	33.9 (10.32)
Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
		38.5 (9.17)	38.5 (8.74)	37.6 (9.82)	35.8 (9.94)

56. Secondary Outcome

Title	FACIT-Fatigue Score at Weeks 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 0 to 52.
Time Frame	Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
		38.9 (8.84)	39.5 (8.73)	38.6 (9.45)	39.6 (8.78)	37.4 (9.88)
Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
		39.8 (8.64)	39.8 (8.54)	38.9 (9.87)	39.4 (8.78)	38.0 (9.77)

57. Secondary Outcome

Title	Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Weeks 4, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		472	477	319	469
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	469 participants
		27.6 (10.68)	27.8 (10.60)	27.2 (10.20)	26.9 (10.34)
Change from Baseline at Week 4	Number Analyzed	465 participants	470 participants	316 participants	455 participants
		6.3 (8.59)	5.7 (8.77)	5.7 (8.47)	3.8 (8.76)
Change from Baseline at Week 24	Number Analyzed	413 participants	417 participants	273 participants	369 participants
		10.5 (10.63)	10.8 (10.77)	10.3 (9.67)	8.4 (10.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	2.8
	Confidence Interval	(2-Sided) 95%; 1.8 to 3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	2.2
	Confidence Interval	(2-Sided) 95%; 1.2 to 3.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.51
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	2.6
	Confidence Interval	(2-Sided) 95%; 1.5 to 3.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; 1.6 to 3.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments	[Not Specified]

58. Secondary Outcome

Title	Change From Baseline in FACIT-Fatigue Score at Weeks 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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		472	477	319	189	189
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	189 participants	189 participants
		27.6 (10.68)	27.8 (10.60)	27.2 (10.20)	26.8 (10.13)	27.9 (10.56)
Change from Baseline at Week 36	Number Analyzed	393 participants	403 participants	268 participants	176 participants	182 participants
		11.0 (10.22)	11.7 (10.90)	11.3 (10.18)	12.8 (10.76)	9.5 (10.25)
Change from Baseline at Week 52	Number Analyzed	384 participants	376 participants	254 participants	166 participants	172 participants
		11.9 (10.21)	12.2 (10.88)	11.7 (10.79)	12.9 (11.55)	10.1 (10.06)

59. Secondary Outcome

Title	Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Measure Type: Count of Participants; Unit of Measure: Participants
Mobility: Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
	No Problems	130	129	84	100
	Slight Problems	176	173	107	149
	Moderate Problems	113	122	96	150
	Severe Problems	44	46	31	56
	Extreme Problems	5	1	1	2
Mobility: Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
	No Problems	178	177	116	132
	Slight Problems	153	151	103	154
	Moderate Problems	99	97	67	112
	Severe Problems	21	31	21	38
	Extreme Problems	4	1	0	1
Mobility: week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
	No Problems	182	189	117	131
	Slight Problems	142	136	90	126
	Moderate Problems	68	75	57	89
	Severe Problems	19	17	12	24
	Extreme Problems	5	2	1	2
Self-care: Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
	No Problems	177	163	111	138
	Slight Problems	180	183	120	164
	Moderate Problems	86	103	74	124
	Severe Problems	23	20	13	25
	Extreme Problems	2	2	1	6
Self-care: Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
	No Problems	243	222	147	165
	Slight Problems	149	150	102	159
	Moderate Problems	53	74	49	88
	Severe Problems	8	9	9	21
	Extreme Problems	2	2	0	4
Self-care: Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
	No Problems	255	249	157	164
	Slight Problems	109	121	75	140
	Moderate Problems	45	39	36	54
	Severe Problems	4	8	7	14
	Extreme Problems	3	2	2	0
Usual Activities: Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
	No Problems	110	102	69	65
	Slight Problems	203	193	133	195
	Moderate Problems	111	142	90	143
	Severe Problems	38	33	25	52
	Extreme Problems	6	1	2	2
Usual Activities: Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
	No Problems	157	149	97	103
	Slight Problems	200	191	130	184
	Moderate Problems	80	90	67	116
	Severe Problems	16	23	13	32
	Extreme Problems	2	4	0	2
Usual Activities: Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
	No Problems	184	175	109	107
	Slight Problems	164	171	105	163
	Moderate Problems	54	63	52	86
	Severe Problems	13	9	9	15
	Extreme Problems	1	1	2	1
Pain/Discomfort: Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
	No Problems	42	38	26	14
	Slight Problems	215	185	118	157
	Moderate Problems	154	204	127	198
	Severe Problems	51	41	47	80
	Extreme Problems	6	3	1	8
Pain/Discomfort: Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
	No Problems	58	71	34	29
	Slight Problems	260	217	145	200
	Moderate Problems	117	150	106	154
	Severe Problems	20	17	22	51
	Extreme Problems	0	2	0	3
Pain/Discomfort: Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
	No Problems	82	78	56	39
	Slight Problems	226	224	127	196
	Moderate Problems	86	103	82	110
	Severe Problems	21	13	12	27
	Extreme Problems	1	1	0	0
Anxiety/Depression: Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
	No Problems	211	224	151	196
	Slight Problems	163	158	111	149
	Moderate Problems	72	81	44	86
	Severe Problems	21	8	13	25
	Extreme Problems	1	0	0	1
Anxiety/Depression: Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
	No Problems	235	246	152	216
	Slight Problems	154	143	106	137
	Moderate Problems	54	63	44	62
	Severe Problems	12	5	4	19
	Extreme Problems	0	0	1	3
Anxiety/Depression: Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
	No Problems	230	256	160	204
	Slight Problems	136	119	75	120
	Moderate Problems	42	37	33	39
	Severe Problems	8	5	6	8
	Extreme Problems	0	2	3	1

60. Secondary Outcome

Title	Number of Participants by EQ-5D Health Profile Categories at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Measure Type: Count of Participants; Unit of Measure: Participants
Mobility: Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
	No Problems	202	189	122	86	78
	Slight Problems	121	136	82	58	67
	Moderate Problems	58	64	48	26	28
	Severe Problems	13	15	16	7	11
	Extreme Problems	1	1	2	0	0
Mobility: Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
	No Problems	197	187	130	82	77
	Slight Problems	117	115	79	47	61
	Moderate Problems	57	58	38	34	27
	Severe Problems	11	19	10	3	8
	Extreme Problems	4	0	0	1	1
Self-care: Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
	No Problems	254	249	164	114	108
	Slight Problems	104	113	67	45	46
	Moderate Problems	31	36	30	17	25
	Severe Problems	5	5	6	1	5
	Extreme Problems	1	2	3	0	0
Self-care: Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
	No Problems	251	245	159	105	101
	Slight Problems	98	102	72	44	48
	Moderate Problems	30	25	24	16	18
	Severe Problems	5	6	2	1	6
	Extreme Problems	2	1	0	1	1
Usual Activities: Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
	No Problems	176	172	125	82	72
	Slight Problems	160	171	90	71	70
	Moderate Problems	50	52	46	21	36
	Severe Problems	7	9	7	3	5
	Extreme Problems	2	1	2	0	1
Usual Activities: Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
	No Problems	183	177	121	75	71
	Slight Problems	151	147	87	64	72
	Moderate Problems	40	41	42	22	19
	Severe Problems	8	12	6	5	12
	Extreme Problems	4	2	1	1	0
Pain/Discomfort: Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
	No Problems	95	84	55	47	35
	Slight Problems	206	220	127	94	97
	Moderate Problems	81	89	79	34	45
	Severe Problems	13	11	8	2	7
	Extreme Problems	0	1	1	0	0
Pain/Discomfort: Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
	No Problems	90	88	57	45	44
	Slight Problems	209	210	130	80	93
	Moderate Problems	77	72	61	38	31
	Severe Problems	10	9	9	3	6
	Extreme Problems	0	0	0	1	0
Anxiety/Depression: Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
	No Problems	230	259	162	115	112
	Slight Problems	123	113	79	44	51
	Moderate Problems	37	27	19	18	16
	Severe Problems	4	5	7	0	5
	Extreme Problems	1	1	3	0	0
Anxiety/Depression: Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
	No Problems	227	254	169	111	110
	Slight Problems	106	86	61	38	41
	Moderate Problems	48	34	23	17	19
	Severe Problems	5	5	4	0	4
	Extreme Problems	0	0	0	1	0

61. Secondary Outcome

Title	EQ-5D Current Health VAS at Weeks 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
		59 (20.5)	59 (19.9)	60 (20.4)	56 (19.5)
Week 12	Number Analyzed	455 participants	457 participants	307 participants	437 participants
		66 (20.3)	66 (20.3)	65 (19.6)	59 (20.7)
Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
		67 (23.1)	69 (21.6)	68 (22.2)	64 (21.4)

62. Secondary Outcome

Title	EQ-5D Current Health VAS at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Week 36	Number Analyzed	395 participants	405 participants	270 participants	177 participants	184 participants
		69 (22.7)	72 (21.2)	67 (24.3)	73 (19.9)	71 (21.1)
Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
		72 (21.3)	73 (21.0)	71 (22.5)	73 (20.6)	70 (22.8)

63. Secondary Outcome

Title	Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
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, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		472	477	319	469
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	469 participants
		48 (22.5)	49 (22.8)	47 (21.8)	46 (21.8)
Change from Baseline at Week 4	Number Analyzed	465 participants	470 participants	316 participants	455 participants
		11 (24.4)	10 (25.2)	13 (24.4)	10 (25.1)
Change from Baseline at Week 12	Number Analyzed	452 participants	455 participants	304 participants	432 participants
		18 (26.3)	17 (27.4)	17 (27.1)	13 (26.5)
Change from Baseline at Week 24	Number Analyzed	413 participants	417 participants	273 participants	369 participants
		19 (30.5)	21 (28.9)	21 (28.8)	18 (29.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	0.049
	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	2.0
	Confidence Interval	(2-Sided) 95%; 0.0 to 5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	0.069
	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%; -0.0 to 5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	7.0
	Confidence Interval	(2-Sided) 95%; 4.0 to 9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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%; 4.0 to 9.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo 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	0.060
	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 6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo 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	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]

64. Secondary Outcome

Title	Change From Baseline in EQ-5D Current Health VAS at Weeks 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 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		472	477	319	189	189
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	189 participants	189 participants
		48 (22.5)	49 (22.8)	47 (21.8)	45 (21.6)	47 (21.1)
Change from Baseline at Week 36	Number Analyzed	393 participants	403 participants	268 participants	176 participants	182 participants
		21 (30.6)	23 (28.5)	20 (30.9)	28 (28.2)	24 (26.0)
Change from Baseline at Week 52	Number Analyzed	384 participants	376 participants	254 participants	166 participants	172 participants
		25 (29.3)	24 (28.5)	24 (29.2)	29 (28.6)	23 (29.6)

65. Secondary Outcome

Title	Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Week 4	Number Analyzed	191 participants	185 participants	112 participants	161 participants
		8.5 (21.27)	6.6 (16.47)	9.2 (21.99)	9.4 (21.41)
Week 12	Number Analyzed	189 participants	177 participants	111 participants	153 participants
		6.6 (17.06)	5.4 (14.56)	7.1 (18.46)	9.5 (22.66)
Week 24	Number Analyzed	178 participants	168 participants	112 participants	132 participants
		4.4 (13.54)	3.6 (10.24)	7.2 (17.72)	10.5 (21.86)

66. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Week 36	Number Analyzed	178 participants	169 participants	106 participants	72 participants	63 participants
		5.5 (16.17)	7.7 (19.46)	7.0 (19.65)	6.8 (19.79)	8.4 (19.97)
Week 52	Number Analyzed	180 participants	156 participants	99 participants	66 participants	55 participants
		4.8 (14.39)	5.4 (15.10)	7.4 (20.12)	5.5 (13.24)	5.8 (14.29)

67. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Week 4	Number Analyzed	185 participants	182 participants	108 participants	156 participants
		34.3 (22.69)	36.9 (24.01)	35.6 (22.39)	42.5 (23.54)
Week 12	Number Analyzed	187 participants	176 participants	109 participants	147 participants
		26.3 (21.07)	26.9 (22.57)	27.6 (21.51)	34.0 (21.98)
Week 24	Number Analyzed	177 participants	168 participants	110 participants	128 participants
		22.0 (21.28)	21.0 (20.74)	25.7 (21.99)	30.9 (23.11)

68. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Week 36	Number Analyzed	176 participants	166 participants	103 participants	71 participants	62 participants
		20.2 (19.54)	19.6 (20.27)	21.2 (20.74)	21.5 (18.72)	25.8 (23.51)
Week 52	Number Analyzed	179 participants	155 participants	97 participants	66 participants	55 participants
		18.2 (18.83)	17.3 (19.25)	20.8 (21.78)	22.3 (21.82)	19.5 (20.04)

69. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: percentage of work productivity loss
Week 4	Number Analyzed	185 participants	182 participants	108 participants	156 participants
		37.0 (24.64)	39.5 (25.17)	38.4 (24.59)	45.1 (25.18)
Week 12	Number Analyzed	187 participants	176 participants	109 participants	147 participants
		29.5 (24.25)	29.3 (24.73)	30.7 (24.34)	36.7 (24.27)
Week 24	Number Analyzed	177 participants	168 participants	110 participants	128 participants
		24.4 (23.06)	23.2 (22.64)	29.1 (23.88)	34.9 (26.04)

70. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: percentage of work productivity loss
Week 36	Number Analyzed	176 participants	166 participants	103 participants	71 participants	62 participants
		23.3 (22.02)	23.9 (23.98)	23.8 (22.95)	24.0 (21.33)	29.1 (26.79)
Week 52	Number Analyzed	179 participants	155 participants	97 participants	66 participants	55 participants
		20.6 (21.74)	20.5 (22.15)	24.3 (24.77)	25.7 (24.32)	22.3 (24.10)

71. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Week 4	Number Analyzed	468 participants	471 participants	319 participants	457 participants
		44.6 (24.18)	46.2 (24.05)	46.4 (23.84)	52.1 (23.41)
Week 12	Number Analyzed	455 participants	457 participants	306 participants	437 participants
		35.1 (23.86)	36.6 (24.51)	38.3 (25.57)	44.3 (23.73)
Week 24	Number Analyzed	416 participants	419 participants	277 participants	372 participants
		30.2 (24.69)	30.4 (23.07)	32.5 (24.40)	39.3 (23.69)

72. Secondary Outcome

Title	WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Time Frame	Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Week 36	Number Analyzed	395 participants	404 participants	270 participants	177 participants	184 participants
		28.3 (23.30)	28.7 (23.47)	31.3 (25.44)	28.3 (22.47)	32.3 (23.62)
Week 52	Number Analyzed	386 participants	379 participants	257 participants	167 participants	174 participants
		26.0 (22.44)	26.3 (22.71)	28.1 (24.38)	28.6 (23.57)	28.9 (23.07)

73. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		195	193	127	162
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Baseline	Number Analyzed	195 participants	193 participants	127 participants	162 participants
		12.0 (25.77)	9.9 (20.91)	16.0 (27.57)	17.0 (29.52)
Change from Baseline at Week 4	Number Analyzed	176 participants	169 participants	107 participants	143 participants
		-1.4 (21.24)	-2.1 (18.14)	-7.5 (24.26)	-5.7 (25.65)
Change from Baseline at Week 12	Number Analyzed	167 participants	160 participants	103 participants	129 participants
		-4.3 (22.55)	-3.8 (18.37)	-7.5 (28.79)	-5.9 (27.94)
Change from Baseline at Week 24	Number Analyzed	157 participants	148 participants	100 participants	110 participants
		-6.1 (24.77)	-3.8 (16.92)	-9.3 (28.99)	-1.5 (27.24)

74. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		195	193	127	76	62
Mean (Standard Deviation); Unit of Measure: percentage of work time missed
Baseline	Number Analyzed	195 participants	193 participants	127 participants	76 participants	62 participants
		12.0 (25.77)	9.9 (20.91)	16.0 (27.57)	18.3 (31.61)	14.6 (26.88)
Change from Baseline at Week 36	Number Analyzed	149 participants	143 participants	94 participants	63 participants	48 participants
		-4.4 (24.04)	-1.5 (24.41)	-8.7 (27.43)	-6.2 (30.25)	-7.5 (25.00)
Change from Baseline at Week 52	Number Analyzed	154 participants	131 participants	89 participants	55 participants	43 participants
		-6.8 (26.27)	-1.7 (21.89)	-7.1 (24.00)	-7.4 (26.76)	-8.9 (27.90)

75. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		184	187	119	150
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Baseline	Number Analyzed	184 participants	187 participants	119 participants	150 participants
		49.1 (25.23)	48.0 (24.61)	50.8 (22.98)	52.5 (25.89)
Change from Baseline at Week 4	Number Analyzed	166 participants	164 participants	100 participants	132 participants
		-15.1 (23.19)	-10.2 (22.82)	-15.3 (24.84)	-9.5 (23.68)
Change from Baseline at Week 12	Number Analyzed	160 participants	156 participants	96 participants	118 participants
		-24.1 (25.83)	-21.9 (23.22)	-22.9 (24.88)	-17.1 (27.24)
Change from Baseline at Week 24	Number Analyzed	151 participants	146 participants	93 participants	102 participants
		-27.4 (26.37)	-25.9 (26.59)	-23.3 (27.56)	-21.2 (29.33)

76. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		184	187	119	69	59
Mean (Standard Deviation); Unit of Measure: percentage of impairment while working
Baseline	Number Analyzed	184 participants	187 participants	119 participants	69 participants	59 participants
		49.1 (25.23)	48.0 (24.61)	50.8 (22.98)	53.8 (26.35)	53.6 (23.40)
Change from Baseline at Week 36	Number Analyzed	144 participants	138 participants	87 participants	61 participants	45 participants
		-29.7 (26.73)	-27.5 (26.28)	-27.8 (29.90)	-32.0 (26.82)	-26.4 (29.86)
Change from Baseline at Week 52	Number Analyzed	144 participants	128 participants	84 participants	52 participants	40 participants
		-31.7 (27.44)	-29.5 (24.66)	-29.4 (27.91)	-30.6 (28.24)	-32.5 (28.17)

77. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		184	187	119	150
Mean (Standard Deviation); Unit of Measure: percentage of work productivity loss
Baseline	Number Analyzed	184 participants	187 participants	119 participants	150 participants
		51.3 (25.95)	50.6 (25.87)	54.3 (24.85)	55.8 (27.33)
Change from Baseline at Week 4	Number Analyzed	166 participants	164 participants	100 participants	132 participants
		-14.6 (24.59)	-10.2 (23.71)	-16.8 (26.29)	-10.0 (24.06)
Change from Baseline at Week 12	Number Analyzed	160 participants	156 participants	96 participants	118 participants
		-23.2 (28.18)	-22.3 (24.34)	-22.8 (26.61)	-17.5 (28.09)
Change from Baseline at Week 24	Number Analyzed	151 participants	146 participants	93 participants	102 participants
		-27.1 (27.78)	-26.3 (27.29)	-23.6 (29.40)	-19.3 (30.81)

78. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		184	187	119	69	59
Mean (Standard Deviation); Unit of Measure: percentage of work productivity loss
Baseline	Number Analyzed	184 participants	187 participants	119 participants	69 participants	59 participants
		51.3 (25.95)	50.6 (25.87)	54.3 (24.85)	56.6 (27.36)	57.1 (25.14)
Change from Baseline at Week 36	Number Analyzed	144 participants	138 participants	87 participants	61 participants	45 participants
		-28.9 (27.16)	-25.7 (29.54)	-28.6 (31.48)	-31.7 (30.53)	-26.9 (31.02)
Change from Baseline at Week 52	Number Analyzed	144 participants	128 participants	84 participants	52 participants	40 participants
		-31.6 (29.17)	-28.4 (27.11)	-29.3 (29.38)	-30.3 (30.73)	-32.7 (29.65)

79. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		472	477	319	469
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Baseline	Number Analyzed	472 participants	477 participants	319 participants	469 participants
		61.5 (22.74)	60.5 (23.85)	61.3 (21.20)	62.2 (22.11)
Change from Baseline at Week 4	Number Analyzed	465 participants	470 participants	316 participants	455 participants
		-17.0 (22.46)	-14.7 (22.07)	-14.8 (23.36)	-9.8 (20.98)
Change from Baseline at Week 12	Number Analyzed	452 participants	455 participants	303 participants	432 participants
		-26.5 (25.17)	-24.1 (24.95)	-22.6 (24.93)	-16.9 (25.98)
Change from Baseline at Week 24	Number Analyzed	413 participants	417 participants	273 participants	369 participants
		-30.7 (26.20)	-30.4 (25.45)	-28.6 (24.99)	-21.9 (27.78)

80. Secondary Outcome

Title	Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Description	The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Overall Number of Participants Analyzed		472	477	319	189	189
Mean (Standard Deviation); Unit of Measure: percentage of activity impairment
Baseline	Number Analyzed	472 participants	477 participants	319 participants	189 participants	189 participants
		61.5 (22.74)	60.5 (23.85)	61.3 (21.20)	62.9 (21.74)	59.7 (22.10)
Change from Baseline at Week 36	Number Analyzed	393 participants	402 participants	268 participants	176 participants	182 participants
		-32.6 (26.66)	-31.5 (25.66)	-30.2 (26.93)	-34.9 (26.60)	-27.5 (26.14)
Change from Baseline at Week 52	Number Analyzed	384 participants	376 participants	254 participants	166 participants	172 participants
		-34.8 (26.74)	-33.7 (26.44)	-32.9 (26.03)	-35.2 (28.00)	-30.8 (25.99)

Adverse Events

Time Frame	First dose date up to last dose date (Maximum: 54 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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo
Arm/Group Description	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
All-Cause Mortality
	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/475 (0.63%)	1/480 (0.21%)	1/325 (0.31%)	1/190 (0.53%)	1/191 (0.52%)	2/475 (0.42%)
Serious Adverse Events
	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	35/475 (7.37%)	40/480 (8.33%)	22/325 (6.77%)	7/190 (3.68%)	8/191 (4.19%)	21/475 (4.42%)
Blood and lymphatic system disorders
Anaemia † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Febrile neutropenia † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Pancytopenia † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Cardiac disorders
Acute myocardial infarction † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Angina unstable † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Cor pulmonale chronic † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Coronary artery disease † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Myocardial infarction † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Sinus tachycardia † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Ear and labyrinth disorders
Meniere's disease † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Vertigo † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Eye disorders
Cataract † 1	1/475 (0.21%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Macular fibrosis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Vitreous opacities † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Colitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Duodenal ulcer perforation † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Gastritis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Gastrointestinal inflammation † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Inguinal hernia † 1	0/475 (0.00%)	2/480 (0.42%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Intestinal haemorrhage † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Mouth ulceration † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Obstructive pancreatitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pancreatitis † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Pancreatitis acute † 1	1/475 (0.21%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Peptic ulcer † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Stomatitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Vomiting † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
General disorders
Chest pain † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Hepatobiliary disorders
Cholecystitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Cholecystitis acute † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Cholelithiasis † 1	2/475 (0.42%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Infections and infestations
Abscess limb † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Appendicitis † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Arthritis infective † 1	1/475 (0.21%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Bronchitis † 1	2/475 (0.42%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Candida infection † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Cellulitis † 1	1/475 (0.21%)	1/480 (0.21%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Erysipelas † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Gastroenteritis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Helicobacter infection † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Infected skin ulcer † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Infectious pleural effusion † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Infective tenosynovitis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Osteomyelitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Paronychia † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pneumocystis jirovecii pneumonia † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pneumonia † 1	4/475 (0.84%)	4/480 (0.83%)	3/325 (0.92%)	1/190 (0.53%)	0/191 (0.00%)	1/475 (0.21%)
Pneumonia bacterial † 1	0/475 (0.00%)	1/480 (0.21%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pneumonia fungal † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Pneumonia pneumococcal † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Pneumonia viral † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pyelonephritis acute † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Sepsis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Septic shock † 1	2/475 (0.42%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Sinusitis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Tooth abscess † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Urinary tract infection † 1	1/475 (0.21%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Varicella † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Coronary artery restenosis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Femoral neck fracture † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Femur fracture † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Hip fracture † 1	1/475 (0.21%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Meniscus injury † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Road traffic accident † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Scapula fracture † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Toxicity to various agents † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Investigations
Alanine aminotransferase increased † 1	1/475 (0.21%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Aspartate aminotransferase increased † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Blood creatinine increased † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Lipase increased † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Electrolyte imbalance † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Hypervitaminosis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Hypoglycaemia † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Metabolic acidosis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Arthritis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Foot deformity † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Intervertebral disc disorder † 1	0/475 (0.00%)	1/480 (0.21%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Limb asymmetry † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Muscular weakness † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Osteonecrosis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Rheumatoid arthritis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	1/475 (0.21%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Breast cancer stage I † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Cervix carcinoma stage III † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Leiomyosarcoma metastatic † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Malignant glioma † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Metastases to liver † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pancreatic carcinoma † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Prostate cancer † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Uterine leiomyoma † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Nervous system disorders
Carotid artery stenosis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Dizziness † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Hemiplegia † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Ischaemic stroke † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	1/191 (0.52%)	0/475 (0.00%)
Syncope † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Transient ischaemic attack † 1	0/475 (0.00%)	2/480 (0.42%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Psychiatric disorders
Adjustment disorder with depressed mood † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Renal and urinary disorders
Acute kidney injury † 1	1/475 (0.21%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Nephrolithiasis † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Prerenal failure † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Renal cell dysplasia † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Reproductive system and breast disorders
Metrorrhagia † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Prostatitis † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	1/191 (0.52%)	0/475 (0.00%)
Uterine haemorrhage † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Vaginal haemorrhage † 1	0/475 (0.00%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	2/475 (0.42%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Alveolitis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Bronchiectasis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Organising pneumonia † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Pulmonary embolism † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Pulmonary fibrosis † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Pulmonary oedema † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Respiratory failure † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Rheumatoid lung † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Vocal cord polyp † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
Skin and subcutaneous tissue disorders
Angioedema † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Dermatitis † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Pustular psoriasis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Skin ulcer † 1	1/475 (0.21%)	1/480 (0.21%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	0/475 (0.00%)	0/480 (0.00%)	1/325 (0.31%)	1/190 (0.53%)	0/191 (0.00%)	0/475 (0.00%)
Hypotension † 1	1/475 (0.21%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	0/475 (0.00%)
Peripheral artery occlusion † 1	0/475 (0.00%)	0/480 (0.00%)	0/325 (0.00%)	0/190 (0.00%)	0/191 (0.00%)	1/475 (0.21%)
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	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	128/475 (26.95%)	142/480 (29.58%)	82/325 (25.23%)	36/190 (18.95%)	23/191 (12.04%)	61/475 (12.84%)
Gastrointestinal disorders
Nausea † 1	26/475 (5.47%)	16/480 (3.33%)	6/325 (1.85%)	4/190 (2.11%)	1/191 (0.52%)	7/475 (1.47%)
Infections and infestations
Nasopharyngitis † 1	43/475 (9.05%)	48/480 (10.00%)	24/325 (7.38%)	7/190 (3.68%)	6/191 (3.14%)	25/475 (5.26%)
Upper respiratory tract infection † 1	41/475 (8.63%)	49/480 (10.21%)	21/325 (6.46%)	8/190 (4.21%)	6/191 (3.14%)	14/475 (2.95%)
Urinary tract infection † 1	18/475 (3.79%)	19/480 (3.96%)	17/325 (5.23%)	10/190 (5.26%)	8/191 (4.19%)	6/475 (1.26%)
Investigations
Alanine aminotransferase increased † 1	17/475 (3.58%)	25/480 (5.21%)	21/325 (6.46%)	7/190 (3.68%)	3/191 (1.57%)	11/475 (2.32%)
Aspartate aminotransferase increased † 1	12/475 (2.53%)	20/480 (4.17%)	17/325 (5.23%)	8/190 (4.21%)	3/191 (1.57%)	9/475 (1.89%)
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:

Combe B, Kivitz A, Tanaka Y, van der Heijde D, Matzkies F, Bartok B, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2):A77.

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.

Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, Kumar U, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy JS, Jahreis A, Genovese MC, Mozaffarian N, Landewe RBM, Bae SC, Keystone EC, Nash P. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis. 2021 Jul;80(7):848-858. doi: 10.1136/annrheumdis-2020-219214. Epub 2021 Jan 27.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02889796
• Other Study ID Numbers: GS-US-417-0301; 2016-000568-41 ( EudraCT Number )
• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Results First Submitted: December 21, 2020
• Results First Posted: January 19, 2021
• Last Update Posted: June 9, 2021