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

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

Study Description

Brief Summary:

The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: MTX; Drug: Placebo to match MTX	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
• Actual Study Start Date: August 8, 2016
• Actual Primary Completion Date: October 5, 2018
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Filgotinib 200 mg + MTX; Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly
Experimental: Filgotinib 100 mg + MTX; Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly
Experimental: Filgotinib 200 mg Monotherapy; Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: Placebo to match MTX; Capsule(s) administered orally once weekly
Active Comparator: MTX Monotherapy; Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg	Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
2. Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 [ Time Frame: Week 24 ]
   The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
3. Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 [ Time Frame: Baseline; Week 24 ]
   Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
4. Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   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.
5. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 [ Time Frame: Baseline; Week 24 ]
   FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
6. Change From Baseline in the mTSS at Week 52 [ Time Frame: Baseline; Week 52 ]
   Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
7. Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 36, and 52 ]
   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.
8. Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 24, 36, and 52 ]
   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.
9. Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 24, 36, and 52 ]
   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.
10. Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 36, and 52 ]
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability).
11. Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    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.
12. Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
13. Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    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.
14. Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    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.
15. Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    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.
16. Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
17. Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 24, 36, and 52 ]
    The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
18. Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
19. Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 [ Time Frame: Weeks 4, 12, 24, and 52 ]
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
20. Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 36, and 52 ]
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
21. ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 24, 36, and 52 ]
    ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
22. Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Weeks 2, 4, 12, 24, 36, and 52 ]

    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.

23. Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    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.
24. Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52 ]
    SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement.
25. Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 [ Time Frame: Baseline; Weeks 24, and 52 ]
    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).
26. SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    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.
27. Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 36, and 52 ]
    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.
28. SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    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.
29. Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    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.
30. FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52.
31. Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 36, and 52 ]
    FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
32. Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    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.
33. EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    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.
34. Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    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).
35. Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
36. WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
37. WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
38. WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
39. Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
40. Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
41. Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
42. Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 [ Time Frame: Baseline; Weeks 4, 12, 24, 36, and 52 ]
    The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.
• Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
• Limited or no prior treatment with MTX

Key Exclusion Criteria:

• Previous treatment with any janus kinase (JAK) inhibitor
• Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
• Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

United States, Alabama

Huntsville, Alabama, United States

United States, Arizona

Phoenix, Arizona, United States

Tucson, Arizona, United States

United States, California

Covina, California, United States

Los Angeles, California, United States

Palm Desert, California, United States

Victorville, California, United States

Whittier, California, United States

United States, Florida

DeBary, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Plantation, Florida, United States

United States, Illinois

Springfield, Illinois, United States

United States, Kansas

Wichita, Kansas, United States

United States, Kentucky

Elizabethtown, Kentucky, United States

United States, Maryland

Cumberland, Maryland, United States

Wheaton, Maryland, United States

United States, Massachusetts

Worcester, Massachusetts, United States

United States, Michigan

Saint Clair Shores, Michigan, United States

United States, Minnesota

Eagan, Minnesota, United States

United States, Mississippi

Hattiesburg, Mississippi, United States

Tupelo, Mississippi, United States

United States, Missouri

Saint Louis, Missouri, United States

United States, Nebraska

Lincoln, Nebraska, United States

United States, New Hampshire

Lebanon, New Hampshire, United States

United States, New Jersey

Freehold, New Jersey, United States

Toms River, New Jersey, United States

United States, New Mexico

Albuquerque, New Mexico, United States

United States, North Carolina

Charlotte, North Carolina, United States

United States, Oklahoma

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

United States, Pennsylvania

Bethlehem, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

United States, South Carolina

Charleston, South Carolina, United States

Orangeburg, South Carolina, United States

United States, Tennessee

Memphis, Tennessee, United States

United States, Texas

Beaumont, Texas, United States

Carrollton, Texas, United States

Corpus Christi, Texas, United States

Mesquite, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Webster, Texas, United States

Argentina

Buenos Aires, Argentina

Caba, Argentina

Mendoza, Argentina

Quilmes, Argentina

San Fernando, Argentina

San Juan, Argentina

San Miguel de Tucumán, Argentina

Australia, Queensland

Maroochydore, Queensland, Australia

Australia, Tasmania

Hobart, Tasmania, Australia

Australia, Western Australia

Victoria Park, Western Australia, Australia

Belgium

Leuven, Flemish Brabant, Belgium

Genk, Belgium

Hasselt, Belgium

Merksem, Belgium

Bulgaria

Dobrich, Bulgaria

Haskovo, Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Vidin, Bulgaria

Canada, Ontario

Barrie, Ontario, Canada

Canada, Quebec

Trois-Rivieres, Quebec, Canada

Chile

Santiago, Chile

Temuco, Chile

Czechia

Ostrava, Czechia

Prague 2, Czechia

Praha 4, Czechia

Uherske Hradiste, Czechia

Germany

Aachen, Germany

Hamburg, Germany

Ratingen, Germany

Hong Kong

Hong Kong, Hong Kong

Tuen Mun, Hong Kong

Hungary

Kalocsa, Bacs-Kiskun, Hungary

Székesfehérvár, Fejer, Hungary

Budapest, Hungary

Kistarcsa, Hungary

India

Ahmedabad, India

Bangalore, India

Delhi, India

Jaipur, India

Kolkata, India

Lucknow, India

Mangalore, India

Mysuru, India

Nagpur, India

New Delhi, India

Pune, India

Secunderabad, India

Srikakulam, India

Surat, India

Vadodara, India

Visakhapatnam, India

Ireland

Dublin 4, Ireland

Israel

Petaẖ Tiqwa, Israel

Italy

Bologna, Italy

Reggio Emilia, Italy

Japan

Fukuoka, Japan

Hamamatsu, Japan

Hiroshima, Japan

Kagoshima, Japan

Katō, Japan

Kawagoe, Japan

Miyagi, Japan

Nagaoka, Japan

Nagasaki, Japan

Okayama, Japan

Sanuki, Japan

Sapporo, Japan

Sasebo, Japan

Sayama, Japan

Tokyo, Japan

Ōme, Japan

Korea, Republic of

Anyang-si, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Incheon, Korea, Republic of

Seoul, Korea, Republic of

Malaysia

Batu Caves, Malaysia

Kuala Lumpur, Malaysia

Mexico

Mérida, Yucatan, Mexico

Chihuahua, Mexico

Distrito Federal, Mexico

Monterrey, Mexico

Morelia, Mexico

Mérida, Mexico

New Zealand

Timaru, Canterbury, New Zealand

Hamilton, New Zealand

Newtown, New Zealand

Papatoetoe, New Zealand

Poland

Białystok, Poland

Bydgoszcz, Poland

Bytom, Poland

Dąbrówka, Poland

Elbląg, Poland

Gdynia, Poland

Katowice, Poland

Krakow, Poland

Nowa Sól, Poland

Poznan, Poland

Toruń, Poland

Warszawa, Poland

Romania

Targu Mures, Mures, Romania

Bucharest, Romania

Oradea, Romania

Russian Federation

Barnaul, Russian Federation

Kemerovo, Russian Federation

Moscow, Russian Federation

Nizhniy Novgorod, Russian Federation

Saratov, Russian Federation

Yaroslavl, Russian Federation

Serbia

Belgrade, Serbia

Slovakia

Bratislava, Slovakia

Prievidza, Slovakia

Topol'cany, Slovakia

South Africa

Cape Town, South Africa

Durban, South Africa

Spain

Sabadell, Barcelona, Spain

Barakaldo, Spain

La Coruña, Spain

Málaga, Spain

Sabadell, Spain

Santiago de Compostela, Spain

Valencia, Spain

Taiwan

Kaohsiung, Taiwan

Taichung, Taiwan

Tainan, Taiwan

Taipei, Taiwan

Taoyuan, Taiwan

Thailand

Bangkok, Thailand

Chiang Mai, Thailand

Songkhla, Thailand

Ukraine

Dnipro, Ukraine

Kharkiv, Ukraine

Kherson, Ukraine

Kyiv, Ukraine

L'viv, Ukraine

Vinnitsa, Ukraine

Vinnytsya, Ukraine

Zaporizhzhya, Ukraine

United Kingdom

Edinburgh, United Kingdom

Newcastle upon Tyne, United Kingdom

Sponsors and Collaborators

Gilead Sciences

Galapagos NV

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

  Study Documents (Full-Text)

Documents provided by Gilead Sciences:

Study Protocol  [PDF] July 5, 2016

Statistical Analysis Plan  [PDF] August 6, 2018

More Information

Publications of Results:

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

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

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

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

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

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

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

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

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases