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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02886728
Collaborator
Galapagos NV (Industry)
1,252
Enrollment
187
Locations
4
Arms
33
Actual Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Aug 8, 2016
Actual Primary Completion Date :
Oct 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Huntsville Alabama United States
    2 Phoenix Arizona United States
    3 Tucson Arizona United States
    4 Covina California United States
    5 Los Angeles California United States
    6 Palm Desert California United States
    7 Victorville California United States
    8 Whittier California United States
    9 DeBary Florida United States
    10 Jacksonville Florida United States
    11 Miami Florida United States
    12 Orlando Florida United States
    13 Plantation Florida United States
    14 Springfield Illinois United States
    15 Wichita Kansas United States
    16 Elizabethtown Kentucky United States
    17 Cumberland Maryland United States
    18 Wheaton Maryland United States
    19 Worcester Massachusetts United States
    20 Saint Clair Shores Michigan United States
    21 Eagan Minnesota United States
    22 Hattiesburg Mississippi United States
    23 Tupelo Mississippi United States
    24 Saint Louis Missouri United States
    25 Lincoln Nebraska United States
    26 Lebanon New Hampshire United States
    27 Freehold New Jersey United States
    28 Toms River New Jersey United States
    29 Albuquerque New Mexico United States
    30 Charlotte North Carolina United States
    31 Oklahoma City Oklahoma United States
    32 Tulsa Oklahoma United States
    33 Bethlehem Pennsylvania United States
    34 Duncansville Pennsylvania United States
    35 Wyomissing Pennsylvania United States
    36 Charleston South Carolina United States
    37 Orangeburg South Carolina United States
    38 Memphis Tennessee United States
    39 Beaumont Texas United States
    40 Carrollton Texas United States
    41 Corpus Christi Texas United States
    42 Mesquite Texas United States
    43 Plano Texas United States
    44 San Antonio Texas United States
    45 Webster Texas United States
    46 Buenos Aires Argentina
    47 Caba Argentina
    48 Mendoza Argentina
    49 Quilmes Argentina
    50 San Fernando Argentina
    51 San Juan Argentina
    52 San Miguel de Tucumán Argentina
    53 Maroochydore Queensland Australia
    54 Hobart Tasmania Australia
    55 Victoria Park Western Australia Australia
    56 Leuven Flemish Brabant Belgium
    57 Genk Belgium
    58 Hasselt Belgium
    59 Merksem Belgium
    60 Dobrich Bulgaria
    61 Haskovo Bulgaria
    62 Plovdiv Bulgaria
    63 Sofia Bulgaria
    64 Varna Bulgaria
    65 Vidin Bulgaria
    66 Barrie Ontario Canada
    67 Trois-Rivieres Quebec Canada
    68 Santiago Chile
    69 Temuco Chile
    70 Ostrava Czechia
    71 Prague 2 Czechia
    72 Praha 4 Czechia
    73 Uherske Hradiste Czechia
    74 Aachen Germany
    75 Hamburg Germany
    76 Ratingen Germany
    77 Hong Kong Hong Kong
    78 Tuen Mun Hong Kong
    79 Kalocsa Bacs-Kiskun Hungary
    80 Székesfehérvár Fejer Hungary
    81 Budapest Hungary
    82 Kistarcsa Hungary
    83 Ahmedabad India
    84 Bangalore India
    85 Delhi India
    86 Jaipur India
    87 Kolkata India
    88 Lucknow India
    89 Mangalore India
    90 Mysuru India
    91 Nagpur India
    92 New Delhi India
    93 Pune India
    94 Secunderabad India
    95 Srikakulam India
    96 Surat India
    97 Vadodara India
    98 Visakhapatnam India
    99 Dublin 4 Ireland
    100 Petaẖ Tiqwa Israel
    101 Bologna Italy
    102 Reggio Emilia Italy
    103 Fukuoka Japan
    104 Hamamatsu Japan
    105 Hiroshima Japan
    106 Kagoshima Japan
    107 Katō Japan
    108 Kawagoe Japan
    109 Miyagi Japan
    110 Nagaoka Japan
    111 Nagasaki Japan
    112 Okayama Japan
    113 Sanuki Japan
    114 Sapporo Japan
    115 Sasebo Japan
    116 Sayama Japan
    117 Tokyo Japan
    118 Ōme Japan
    119 Anyang-si Korea, Republic of
    120 Daegu Korea, Republic of
    121 Daejeon Korea, Republic of
    122 Incheon Korea, Republic of
    123 Seoul Korea, Republic of
    124 Batu Caves Malaysia
    125 Kuala Lumpur Malaysia
    126 Mérida Yucatan Mexico
    127 Chihuahua Mexico
    128 Distrito Federal Mexico
    129 Monterrey Mexico
    130 Morelia Mexico
    131 Mérida Mexico
    132 Timaru Canterbury New Zealand
    133 Hamilton New Zealand
    134 Newtown New Zealand
    135 Papatoetoe New Zealand
    136 Białystok Poland
    137 Bydgoszcz Poland
    138 Bytom Poland
    139 Dąbrówka Poland
    140 Elbląg Poland
    141 Gdynia Poland
    142 Katowice Poland
    143 Krakow Poland
    144 Nowa Sól Poland
    145 Poznan Poland
    146 Toruń Poland
    147 Warszawa Poland
    148 Targu Mures Mures Romania
    149 Bucharest Romania
    150 Oradea Romania
    151 Barnaul Russian Federation
    152 Kemerovo Russian Federation
    153 Moscow Russian Federation
    154 Nizhniy Novgorod Russian Federation
    155 Saratov Russian Federation
    156 Yaroslavl Russian Federation
    157 Belgrade Serbia
    158 Bratislava Slovakia
    159 Prievidza Slovakia
    160 Topol'cany Slovakia
    161 Cape Town South Africa
    162 Durban South Africa
    163 Sabadell Barcelona Spain
    164 Barakaldo Spain
    165 La Coruña Spain
    166 Málaga Spain
    167 Sabadell Spain
    168 Santiago de Compostela Spain
    169 Valencia Spain
    170 Kaohsiung Taiwan
    171 Taichung Taiwan
    172 Tainan Taiwan
    173 Taipei Taiwan
    174 Taoyuan Taiwan
    175 Bangkok Thailand
    176 Chiang Mai Thailand
    177 Songkhla Thailand
    178 Dnipro Ukraine
    179 Kharkiv Ukraine
    180 Kherson Ukraine
    181 Kyiv Ukraine
    182 L'viv Ukraine
    183 Vinnitsa Ukraine
    184 Vinnytsya Ukraine
    185 Zaporizhzhya Ukraine
    186 Edinburgh United Kingdom
    187 Newcastle upon Tyne United Kingdom

    Sponsors and Collaborators

    • Gilead Sciences
    • Galapagos NV

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02886728
    Other Study ID Numbers:
    • GS-US-417-0303
    • 2016-000570-37
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Jun 1, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, and South America. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.
    Pre-assignment Detail 1855 participants were screened.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Period Title: Overall Study
    STARTED 417 207 210 418
    COMPLETED 345 175 174 331
    NOT COMPLETED 72 32 36 87

    Baseline Characteristics

    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy Total
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks. Total of all reporting groups
    Overall Participants 416 207 210 416 1249
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53
    (13.8)
    54
    (12.6)
    52
    (13.9)
    53
    (13.7)
    53
    (13.6)
    Sex: Female, Male (Count of Participants)
    Female
    325
    78.1%
    158
    76.3%
    166
    79%
    312
    75%
    961
    76.9%
    Male
    91
    21.9%
    49
    23.7%
    44
    21%
    104
    25%
    288
    23.1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    26
    6.3%
    12
    5.8%
    18
    8.6%
    33
    7.9%
    89
    7.1%
    Asian: Japanese
    23
    5.5%
    11
    5.3%
    12
    5.7%
    25
    6%
    71
    5.7%
    Asian: Chinese/Taiwanese/Hong Kong Chinese
    7
    1.7%
    4
    1.9%
    6
    2.9%
    10
    2.4%
    27
    2.2%
    Asian: Vietnamese
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%
    Asian: Korean
    6
    1.4%
    8
    3.9%
    2
    1%
    8
    1.9%
    24
    1.9%
    Asian: Other
    53
    12.7%
    28
    13.5%
    27
    12.9%
    42
    10.1%
    150
    12%
    Black or African American
    15
    3.6%
    8
    3.9%
    8
    3.8%
    14
    3.4%
    45
    3.6%
    Native Hawaiian or Pacific Islander
    1
    0.2%
    0
    0%
    1
    0.5%
    3
    0.7%
    5
    0.4%
    White
    278
    66.8%
    132
    63.8%
    135
    64.3%
    278
    66.8%
    823
    65.9%
    Other
    6
    1.4%
    4
    1.9%
    0
    0%
    3
    0.7%
    13
    1%
    Not Permitted
    0
    0%
    0
    0%
    1
    0.5%
    0
    0%
    1
    0.1%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    93
    22.4%
    40
    19.3%
    45
    21.4%
    84
    20.2%
    262
    21%
    Not Hispanic or Latino
    322
    77.4%
    167
    80.7%
    165
    78.6%
    332
    79.8%
    986
    78.9%
    Not Permitted
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%
    Region of Enrollment (Count of Participants)
    United States
    112
    26.9%
    47
    22.7%
    54
    25.7%
    106
    25.5%
    319
    25.5%
    Spain
    12
    2.9%
    5
    2.4%
    7
    3.3%
    10
    2.4%
    34
    2.7%
    Germany
    7
    1.7%
    7
    3.4%
    6
    2.9%
    10
    2.4%
    30
    2.4%
    South Korea
    6
    1.4%
    8
    3.9%
    2
    1%
    8
    1.9%
    24
    1.9%
    Canada
    5
    1.2%
    5
    2.4%
    4
    1.9%
    6
    1.4%
    20
    1.6%
    Belgium
    3
    0.7%
    2
    1%
    6
    2.9%
    8
    1.9%
    19
    1.5%
    South Africa
    8
    1.9%
    5
    2.4%
    1
    0.5%
    5
    1.2%
    19
    1.5%
    Australia
    7
    1.7%
    2
    1%
    2
    1%
    7
    1.7%
    18
    1.4%
    New Zealand
    9
    2.2%
    3
    1.4%
    0
    0%
    4
    1%
    16
    1.3%
    United Kingdom
    1
    0.2%
    1
    0.5%
    1
    0.5%
    5
    1.2%
    8
    0.6%
    Italy
    2
    0.5%
    0
    0%
    1
    0.5%
    0
    0%
    3
    0.2%
    Ireland
    1
    0.2%
    0
    0%
    0
    0%
    1
    0.2%
    2
    0.2%
    Israel
    0
    0%
    0
    0%
    2
    1%
    0
    0%
    2
    0.2%
    India
    41
    9.9%
    21
    10.1%
    22
    10.5%
    31
    7.5%
    115
    9.2%
    Poland
    35
    8.4%
    21
    10.1%
    15
    7.1%
    37
    8.9%
    108
    8.6%
    Ukraine
    21
    5%
    10
    4.8%
    13
    6.2%
    25
    6%
    69
    5.5%
    Bulgaria
    17
    4.1%
    11
    5.3%
    8
    3.8%
    18
    4.3%
    54
    4.3%
    Russia
    9
    2.2%
    4
    1.9%
    4
    1.9%
    14
    3.4%
    31
    2.5%
    Czechia
    5
    1.2%
    3
    1.4%
    3
    1.4%
    9
    2.2%
    20
    1.6%
    Hungary
    7
    1.7%
    2
    1%
    3
    1.4%
    6
    1.4%
    18
    1.4%
    Serbia
    6
    1.4%
    2
    1%
    4
    1.9%
    4
    1%
    16
    1.3%
    Romania
    4
    1%
    1
    0.5%
    2
    1%
    3
    0.7%
    10
    0.8%
    Slovakia
    4
    1%
    0
    0%
    2
    1%
    2
    0.5%
    8
    0.6%
    Mexico
    35
    8.4%
    20
    9.7%
    23
    11%
    38
    9.1%
    116
    9.3%
    Argentina
    16
    3.8%
    5
    2.4%
    4
    1.9%
    15
    3.6%
    40
    3.2%
    Chile
    7
    1.7%
    3
    1.4%
    1
    0.5%
    3
    0.7%
    14
    1.1%
    Taiwan
    7
    1.7%
    2
    1%
    5
    2.4%
    9
    2.2%
    23
    1.8%
    Thailand
    5
    1.2%
    2
    1%
    1
    0.5%
    5
    1.2%
    13
    1%
    Malaysia
    1
    0.2%
    3
    1.4%
    1
    0.5%
    1
    0.2%
    6
    0.5%
    Hong Kong
    0
    0%
    1
    0.5%
    1
    0.5%
    1
    0.2%
    3
    0.2%
    Japan
    23
    5.5%
    11
    5.3%
    12
    5.7%
    25
    6%
    71
    5.7%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Number (95% Confidence Interval) [percentage of participants]
    81.0
    19.5%
    80.2
    38.7%
    78.1
    37.2%
    71.4
    17.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.6
    Confidence Interval (2-Sided) 95%
    3.6 to 15.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 8.8
    Confidence Interval (2-Sided) 95%
    1.5 to 16.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.058
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.7
    Confidence Interval (2-Sided) 95%
    -0.7 to 14.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
    Description The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    1.52
    (0.622)
    1.56
    (0.654)
    1.56
    (0.655)
    1.60
    (0.625)
    Change at Week 24
    -0.94
    (0.722)
    -0.90
    (0.675)
    -0.89
    (0.631)
    -0.79
    (0.634)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.19
    Confidence Interval (2-Sided) 95%
    -0.27 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.041
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.13
    Confidence Interval (2-Sided) 95%
    -0.23 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.049
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.032
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.11
    Confidence Interval (2-Sided) 95%
    -0.20 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.050
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24
    Description The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Number (95% Confidence Interval) [percentage of participants]
    54.1
    13%
    42.5
    20.5%
    42.4
    20.2%
    29.1
    7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 25.0
    Confidence Interval (2-Sided) 95%
    18.3 to 31.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.4
    Confidence Interval (2-Sided) 95%
    5.0 to 21.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.3
    Confidence Interval (2-Sided) 95%
    5.0 to 21.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
    Description Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    11.35
    (19.922)
    13.31
    (26.980)
    16.53
    (32.372)
    13.72
    (29.168)
    Change at Week 24
    0.21
    (1.684)
    0.22
    (1.526)
    -0.04
    (1.710)
    0.51
    (2.887)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.068
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.161
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.67 to 0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.195
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.55
    Confidence Interval (2-Sided) 95%
    -0.94 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.199
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
    Description The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    33.9
    (7.48)
    33.7
    (8.00)
    33.6
    (7.70)
    33.3
    (7.28)
    Change at Week 24
    12.3
    (8.89)
    11.1
    (9.00)
    10.4
    (9.09)
    9.7
    (8.62)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.9
    Confidence Interval (2-Sided) 95%
    1.8 to 4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.021
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    0.2 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.69
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    -0.5 to 2.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.69
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
    Description FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    28.3
    (10.93)
    27.3
    (11.92)
    27.3
    (10.90)
    27.1
    (10.72)
    Change at Week 24
    10.6
    (11.49)
    11.4
    (11.26)
    10.2
    (11.37)
    10.1
    (11.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.056
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -0.0 to 2.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.68
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -0.3 to 3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.67
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -1.3 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in the mTSS at Week 52
    Description Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
    Time Frame Baseline; Week 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    11.31
    (19.273)
    12.76
    (24.363)
    15.89
    (31.813)
    13.36
    (27.736)
    Change at Week 52
    0.31
    (1.808)
    0.23
    (1.111)
    0.33
    (1.902)
    0.81
    (3.089)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.03 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.195
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -1.09 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.236
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.66
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.242
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52
    Description ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 2, 4, 12, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    42.1
    10.1%
    37.2
    18%
    39.5
    18.8%
    16.6
    4%
    Week 4
    62.3
    15%
    55.6
    26.9%
    52.4
    25%
    33.4
    8%
    Week 12
    76.7
    18.4%
    72.0
    34.8%
    71.4
    34%
    59.4
    14.3%
    Week 36
    75.5
    18.1%
    73.4
    35.5%
    76.2
    36.3%
    68.3
    16.4%
    Week 52
    75.0
    18%
    73.4
    35.5%
    74.8
    35.6%
    61.8
    14.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 25.5
    Confidence Interval (2-Sided) 95%
    19.3 to 31.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 20.6
    Confidence Interval (2-Sided) 95%
    12.8 to 28.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 22.9
    Confidence Interval (2-Sided) 95%
    15.1 to 30.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 28.8
    Confidence Interval (2-Sided) 95%
    22.1 to 35.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 22.1
    Confidence Interval (2-Sided) 95%
    13.6 to 30.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 19.0
    Confidence Interval (2-Sided) 95%
    10.5 to 27.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 17.3
    Confidence Interval (2-Sided) 95%
    10.8 to 23.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.6
    Confidence Interval (2-Sided) 95%
    4.5 to 20.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.1
    Confidence Interval (2-Sided) 95%
    4.0 to 20.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.2
    Confidence Interval (2-Sided) 95%
    0.9 to 13.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 5.2
    Confidence Interval (2-Sided) 95%
    -2.7 to 13.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.030
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.9
    Confidence Interval (2-Sided) 95%
    0.3 to 15.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.2
    Confidence Interval (2-Sided) 95%
    6.7 to 19.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.7
    Confidence Interval (2-Sided) 95%
    3.7 to 19.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.0
    Confidence Interval (2-Sided) 95%
    5.1 to 20.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52
    Description ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    13.0
    3.1%
    9.2
    4.4%
    16.2
    7.7%
    2.9
    0.7%
    Week 4
    29.3
    7%
    20.8
    10%
    25.7
    12.2%
    9.4
    2.3%
    Week 12
    53.1
    12.8%
    44.4
    21.4%
    45.7
    21.8%
    28.4
    6.8%
    Week 24
    61.5
    14.8%
    57.0
    27.5%
    58.1
    27.7%
    45.7
    11%
    Week 36
    60.6
    14.6%
    55.6
    26.9%
    58.6
    27.9%
    48.6
    11.7%
    Week 52
    62.3
    15%
    59.4
    28.7%
    61.4
    29.2%
    48.3
    11.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.1
    Confidence Interval (2-Sided) 95%
    6.2 to 13.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.3
    Confidence Interval (2-Sided) 95%
    1.7 to 10.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.3
    Confidence Interval (2-Sided) 95%
    7.7 to 18.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 20.0
    Confidence Interval (2-Sided) 95%
    14.5 to 25.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.4
    Confidence Interval (2-Sided) 95%
    4.8 to 18.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 16.3
    Confidence Interval (2-Sided) 95%
    9.4 to 23.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 24.8
    Confidence Interval (2-Sided) 95%
    18.1 to 31.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 16.1
    Confidence Interval (2-Sided) 95%
    7.7 to 24.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 17.3
    Confidence Interval (2-Sided) 95%
    9.0 to 25.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 15.9
    Confidence Interval (2-Sided) 95%
    8.9 to 22.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.3
    Confidence Interval (2-Sided) 95%
    2.7 to 20.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.4
    Confidence Interval (2-Sided) 95%
    3.9 to 21.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.0
    Confidence Interval (2-Sided) 95%
    5.1 to 19.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.090
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.0
    Confidence Interval (2-Sided) 95%
    -1.7 to 15.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.0
    Confidence Interval (2-Sided) 95%
    1.4 to 18.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.9
    Confidence Interval (2-Sided) 95%
    7.0 to 20.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.1
    Confidence Interval (2-Sided) 95%
    2.5 to 19.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.1
    Confidence Interval (2-Sided) 95%
    4.6 to 21.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52
    Description ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    3.1
    0.7%
    1.9
    0.9%
    4.3
    2%
    0.7
    0.2%
    Week 4
    13.0
    3.1%
    6.3
    3%
    11.4
    5.4%
    3.8
    0.9%
    Week 12
    32.9
    7.9%
    27.1
    13.1%
    29.0
    13.8%
    13.2
    3.2%
    Week 24
    43.8
    10.5%
    40.1
    19.4%
    40.0
    19%
    26.0
    6.3%
    Week 36
    45.9
    11%
    37.2
    18%
    39.5
    18.8%
    32.2
    7.7%
    Week 52
    47.8
    11.5%
    40.1
    19.4%
    45.2
    21.5%
    29.8
    7.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    0.3 to 4.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -1.2 to 3.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 3.6
    Confidence Interval (2-Sided) 95%
    0.3 to 6.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.1
    Confidence Interval (2-Sided) 95%
    5.2 to 13.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    -1.7 to 6.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.6
    Confidence Interval (2-Sided) 95%
    2.5 to 12.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 19.7
    Confidence Interval (2-Sided) 95%
    13.9 to 25.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.8
    Confidence Interval (2-Sided) 95%
    6.6 to 21.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 15.8
    Confidence Interval (2-Sided) 95%
    8.5 to 23.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 17.8
    Confidence Interval (2-Sided) 95%
    11.2 to 24.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.1
    Confidence Interval (2-Sided) 95%
    5.9 to 22.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.0
    Confidence Interval (2-Sided) 95%
    5.8 to 22.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.7
    Confidence Interval (2-Sided) 95%
    6.9 to 20.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 5.0
    Confidence Interval (2-Sided) 95%
    -3.3 to 13.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.056
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.3
    Confidence Interval (2-Sided) 95%
    -1.0 to 15.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 18.0
    Confidence Interval (2-Sided) 95%
    11.3 to 24.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.3
    Confidence Interval (2-Sided) 95%
    1.9 to 18.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 15.4
    Confidence Interval (2-Sided) 95%
    7.0 to 23.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52
    Description The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability).
    Time Frame Baseline; Weeks 2, 4, 12, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    1.52
    (0.622)
    1.56
    (0.654)
    1.56
    (0.655)
    1.60
    (0.625)
    Change at Week 2
    -0.37
    (0.495)
    -0.36
    (0.490)
    -0.32
    (0.442)
    -0.18
    (0.426)
    Change at Week 4
    -0.57
    (0.587)
    -0.45
    (0.547)
    -0.51
    (0.526)
    -0.32
    (0.511)
    Change at Week 12
    -0.85
    (0.698)
    -0.77
    (0.670)
    -0.76
    (0.625)
    -0.61
    (0.582)
    Change at Week 36
    -0.96
    (0.725)
    -0.93
    (0.700)
    -0.91
    (0.673)
    -0.89
    (0.675)
    Change at Week 52
    -1.00
    (0.728)
    -0.97
    (0.719)
    -0.95
    (0.688)
    -0.88
    (0.685)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.23
    Confidence Interval (2-Sided) 95%
    -0.29 to -0.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.031
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.20
    Confidence Interval (2-Sided) 95%
    -0.28 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.038
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.24 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.038
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.35 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.035
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.15
    Confidence Interval (2-Sided) 95%
    -0.23 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.043
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.21
    Confidence Interval (2-Sided) 95%
    -0.29 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.042
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.28
    Confidence Interval (2-Sided) 95%
    -0.35 to -0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.039
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.18
    Confidence Interval (2-Sided) 95%
    -0.28 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.048
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.26 to -0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.048
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.13
    Confidence Interval (2-Sided) 95%
    -0.22 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.043
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -0.17 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.052
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -0.16 to 0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.052
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.25 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.045
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.077
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.10
    Confidence Interval (2-Sided) 95%
    -0.20 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.054
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.039
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.11
    Confidence Interval (2-Sided) 95%
    -0.22 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.054
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52
    Description TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    26
    (14.5)
    25
    (13.9)
    26
    (13.7)
    26
    (13.8)
    Change at Week 2
    -9
    (10.2)
    -8
    (9.8)
    -9
    (11.2)
    -5
    (9.8)
    Change at Week 4
    -13
    (12.1)
    -12
    (10.1)
    -13
    (11.8)
    -8
    (11.5)
    Change at Week 12
    -18
    (12.5)
    -17
    (12.4)
    -18
    (12.4)
    -15
    (12.2)
    Change at Week 24
    -20
    (12.5)
    -20
    (13.0)
    -22
    (12.4)
    -19
    (12.9)
    Change at Week 36
    -21
    (12.6)
    -21
    (12.8)
    -23
    (11.9)
    -21
    (12.7)
    Change at Week 52
    -22
    (12.4)
    -21
    (13.0)
    -23
    (12.3)
    -21
    (12.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.8
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.9
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -7.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.9
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -7.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.7
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.9
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -7.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.9
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -5.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.7
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -5.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.8
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.8
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.063
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.5
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.64
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.095
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52
    Description The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    16.0
    (9.8)
    16.0
    (9.3)
    16.0
    (9.7)
    16.0
    (9.4)
    Change at Week 2
    -7.0
    (8.0)
    -6.0
    (6.9)
    -7.0
    (8.1)
    -4.0
    (7.5)
    Change at Week 4
    -9.0
    (8.7)
    -9.0
    (7.6)
    -9.0
    (8.3)
    -6.0
    (9.2)
    Change at Week 12
    -13.0
    (8.9)
    -12.0
    (8.1)
    -13.0
    (9.1)
    -11.0
    (8.9)
    Change at Week 24
    -14.0
    (8.9)
    -14.0
    (8.8)
    -15.0
    (9.5)
    -13.0
    (8.8)
    Change at Week 36
    -14.0
    (9.1)
    -14.0
    (9.4)
    -15.0
    (9.7)
    -14.0
    (8.7)
    Change at Week 52
    -15.0
    (9.2)
    -14.0
    (8.9)
    -16.0
    (9.8)
    -14.0
    (9.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.7
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -4.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.7
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.4
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -2.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -1.0 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.032
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    14. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52
    Description SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    65.0
    (21.0)
    66.0
    (21.6)
    68.0
    (19.2)
    66.0
    (21.0)
    Change at Week 2
    -17.0
    (20.8)
    -13.0
    (18.9)
    -14.0
    (20.7)
    -7.0
    (18.9)
    Change at Week 4
    -26.0
    (24.7)
    -20.0
    (22.5)
    -22.0
    (24.6)
    -14.0
    (22.2)
    Change at Week 12
    -37.0
    (26.7)
    -30.0
    (26.1)
    -32.0
    (27.7)
    -25.0
    (25.9)
    Change at Week 24
    -42.0
    (26.8)
    -36.0
    (27.4)
    -38.0
    (26.6)
    -34.0
    (27.4)
    Change at Week 36
    -43.0
    (27.2)
    -39.0
    (27.8)
    -39.0
    (24.3)
    -38.0
    (28.0)
    Change at Week 52
    -45.0
    (27.0)
    -41.0
    (28.1)
    -43.0
    (25.4)
    -38.0
    (28.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -11.0
    Confidence Interval (2-Sided) 95%
    -13.0 to -8.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.3
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -12.0
    Confidence Interval (2-Sided) 95%
    -15.0 to -10.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.5
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -12.0
    Confidence Interval (2-Sided) 95%
    -15.0 to -9.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -9.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -13.0 to -6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -7.0 to 1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.066
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -8.0 to 0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.40
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.0 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.0 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -12.0 to -5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.17
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -7.0 to 1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52
    Description PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    66.0
    (17.0)
    68.0
    (16.3)
    66.0
    (14.4)
    67.0
    (16.8)
    Change at Week 2
    -24.0
    (20.3)
    -21.0
    (19.4)
    -23.0
    (19.9)
    -15.0
    (18.9)
    Change at Week 4
    -34.0
    (22.3)
    -32.0
    (22.5)
    -30.0
    (21.9)
    -23.0
    (20.7)
    Change at Week 12
    -47.0
    (21.4)
    -43.0
    (22.5)
    -42.0
    (20.8)
    -38.0
    (21.9)
    Change at Week 24
    -51.0
    (21.1)
    -51.0
    (22.2)
    -49.0
    (19.5)
    -46.0
    (21.4)
    Change at Week 36
    -53.0
    (20.5)
    -51.0
    (22.3)
    -52.0
    (18.6)
    -51.0
    (20.6)
    Change at Week 52
    -56.0
    (20.0)
    -54.0
    (20.7)
    -55.0
    (17.5)
    -51.0
    (20.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -12.0 to -6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.3
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -11.0
    Confidence Interval (2-Sided) 95%
    -13.0 to -8.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -9.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -8.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -8.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.2
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -7.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.5
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.046
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.5
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.2
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.44
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -4.0 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.21
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -5.0 to 1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -7.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.1
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -6.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52
    Description The participant assessed their pain severity using a VAS on a scale of 0 ( no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    64.0
    (22.0)
    67.0
    (22.1)
    67.0
    (18.4)
    66.0
    (21.4)
    Change at Week 2
    -18.0
    (22.2)
    -15.0
    (20.3)
    -17.0
    (21.6)
    -7.0
    (20.1)
    Change at Week 4
    -26.0
    (24.8)
    -22.0
    (23.7)
    -24.0
    (25.3)
    -14.0
    (23.6)
    Change at Week 12
    -37.0
    (27.1)
    -31.0
    (26.9)
    -32.0
    (28.3)
    -26.0
    (27.0)
    Change at Week 24
    -41.0
    (28.0)
    -37.0
    (27.8)
    -39.0
    (26.1)
    -34.0
    (27.6)
    Change at Week 36
    -43.0
    (28.0)
    -40.0
    (28.8)
    -38.0
    (25.6)
    -38.0
    (29.3)
    Change at Week 52
    -45.0
    (27.9)
    -43.0
    (27.9)
    -44.0
    (24.2)
    -37.0
    (30.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -12.0
    Confidence Interval (2-Sided) 95%
    -15.0 to -9.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.4
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -13.0 to -6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.9
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -13.0 to -6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.9
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -12.0
    Confidence Interval (2-Sided) 95%
    -15.0 to -8.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5
    Confidence Interval (2-Sided) 95.0%
    -9.0 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.0
    Confidence Interval (2-Sided) 95%
    -10.0 to -2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -12.0 to -5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.13
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.0
    Confidence Interval (2-Sided) 95%
    -7.0 to 1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.0
    Confidence Interval (2-Sided) 95%
    -8.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.0 to -4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.34
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.0 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.46
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -6.0 to 3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.0
    Confidence Interval (2-Sided) 95%
    -12.0 to -5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.030
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.0
    Confidence Interval (2-Sided) 95%
    -9.0 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.2
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -12.0 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.2
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
    Description
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    18.04
    (25.289)
    17.72
    (27.419)
    17.32
    (23.228)
    16.86
    (24.353)
    Change at Week 2
    -12.89
    (23.401)
    -9.40
    (18.930)
    -10.97
    (20.249)
    -0.99
    (14.392)
    Change at Week 4
    -13.79
    (23.569)
    -11.53
    (20.596)
    -10.95
    (23.319)
    -3.18
    (18.534)
    Change at Week 12
    -13.77
    (23.585)
    -11.02
    (20.272)
    -12.04
    (24.690)
    -7.23
    (21.823)
    Change at Week 24
    -13.43
    (27.086)
    -10.85
    (24.458)
    -12.66
    (24.525)
    -7.47
    (23.511)
    Change at Week 36
    -12.99
    (26.823)
    -12.64
    (22.736)
    -11.52
    (26.863)
    -8.74
    (23.579)
    Change at Week 52
    -13.84
    (25.180)
    -11.61
    (23.857)
    -12.29
    (23.090)
    -7.96
    (23.835)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -10.78
    Confidence Interval (2-Sided) 95%
    -12.71 to -8.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.983
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.76
    Confidence Interval (2-Sided) 95%
    -11.13 to -6.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.207
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.64
    Confidence Interval (2-Sided) 95%
    -12.00 to -7.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.200
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -9.92
    Confidence Interval (2-Sided) 95%
    -11.65 to -8.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.884
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.34
    Confidence Interval (2-Sided) 95%
    -10.47 to -6.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.086
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.33
    Confidence Interval (2-Sided) 95%
    -9.45 to -5.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.080
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.98
    Confidence Interval (2-Sided) 95%
    -7.56 to -4.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.808
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.21
    Confidence Interval (2-Sided) 95%
    -6.14 to -2.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.987
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.34
    Confidence Interval (2-Sided) 95%
    -6.29 to -2.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.993
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.27
    Confidence Interval (2-Sided) 95%
    -7.24 to -3.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.003
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.29
    Confidence Interval (2-Sided) 95%
    -5.68 to -0.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.222
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.61
    Confidence Interval (2-Sided) 95%
    -7.02 to -2.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.229
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.44
    Confidence Interval (2-Sided) 95%
    -5.35 to -1.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.974
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.40
    Confidence Interval (2-Sided) 95%
    -5.72 to -1.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.180
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.072
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.12
    Confidence Interval (2-Sided) 95%
    -4.44 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.180
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.79
    Confidence Interval (2-Sided) 95%
    -6.34 to -3.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.789
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.01
    Confidence Interval (2-Sided) 95%
    -4.88 to -1.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.957
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.77
    Confidence Interval (2-Sided) 95%
    -5.65 to -1.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.957
    Estimation Comments
    18. Secondary Outcome
    Title Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52
    Description The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    61.9
    14.9%
    58.5
    28.3%
    53.9
    25.7%
    42.2
    10.1%
    Week 4
    72.4
    17.4%
    61.0
    29.5%
    68.6
    32.7%
    53.9
    13%
    Week 12
    80.3
    19.3%
    74.5
    36%
    74.0
    35.2%
    69.8
    16.8%
    Week 24
    76.6
    18.4%
    78.5
    37.9%
    77.0
    36.7%
    73.9
    17.8%
    Week 36
    73.4
    17.6%
    76.5
    37%
    73.5
    35%
    67.1
    16.1%
    Week 52
    70.9
    17%
    71.5
    34.5%
    70.6
    33.6%
    61.0
    14.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 19.7
    Confidence Interval (2-Sided) 95%
    12.8 to 26.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 16.3
    Confidence Interval (2-Sided) 95%
    7.6 to 25.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.7
    Confidence Interval (2-Sided) 95%
    3.0 to 20.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 18.5
    Confidence Interval (2-Sided) 95%
    11.7 to 25.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.083
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.1
    Confidence Interval (2-Sided) 95%
    -1.6 to 15.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.7
    Confidence Interval (2-Sided) 95%
    6.4 to 23.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.6
    Confidence Interval (2-Sided) 95%
    4.4 to 16.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.22
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.7
    Confidence Interval (2-Sided) 95%
    -3.1 to 12.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.25
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.3
    Confidence Interval (2-Sided) 95%
    -3.6 to 12.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.35
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 2.7
    Confidence Interval (2-Sided) 95%
    -3.5 to 8.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.6
    Confidence Interval (2-Sided) 95%
    -2.9 to 12.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.36
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 3.1
    Confidence Interval (2-Sided) 95%
    -4.5 to 10.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.3
    Confidence Interval (2-Sided) 95%
    -0.2 to 12.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.4
    Confidence Interval (2-Sided) 95%
    1.6 to 17.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.085
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.5
    Confidence Interval (2-Sided) 95%
    -1.5 to 14.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.9
    Confidence Interval (2-Sided) 95%
    3.2 to 16.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.5
    Confidence Interval (2-Sided) 95%
    2.3 to 18.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.6
    Confidence Interval (2-Sided) 95%
    1.4 to 17.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52
    Description The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    5.7
    (0.99)
    5.7
    (1.04)
    5.8
    (0.94)
    5.7
    (1.00)
    Change at Week 2
    -1.3
    (1.06)
    -1.1
    (0.92)
    -1.4
    (1.12)
    -0.6
    (0.87)
    Change at Week 4
    -1.9
    (1.26)
    -1.6
    (1.14)
    -1.8
    (1.20)
    -1.0
    (1.04)
    Change at Week 12
    -2.7
    (1.31)
    -2.5
    (1.28)
    -2.6
    (1.26)
    -1.9
    (1.21)
    Change at Week 24
    -3.2
    (1.31)
    -2.9
    (1.30)
    -3.0
    (1.16)
    -2.5
    (1.29)
    Change at Week 36
    -3.3
    (1.28)
    -3.0
    (1.26)
    -3.2
    (1.12)
    -2.9
    (1.22)
    Change at Week 52
    -3.4
    (1.23)
    -3.1
    (1.24)
    -3.3
    (1.11)
    -2.8
    (1.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.07
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.7 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.09
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.0 to -0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.09
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -1.0 to -0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -0.8 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -0.9 to -0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.7 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.7 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.6 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -0.4 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.6 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -0.6 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -0.7 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.10
    Estimation Comments
    20. Secondary Outcome
    Title Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52
    Description The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 4, 12, 24, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    30.8
    7.4%
    23.7
    11.4%
    31.9
    15.2%
    12.0
    2.9%
    Week 12
    55.8
    13.4%
    50.2
    24.3%
    48.1
    22.9%
    28.6
    6.9%
    Week 24
    68.8
    16.5%
    62.8
    30.3%
    60.0
    28.6%
    46.2
    11.1%
    Week 52
    69.0
    16.6%
    59.9
    28.9%
    65.7
    31.3%
    47.6
    11.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 18.8
    Confidence Interval (2-Sided) 95%
    13.1 to 24.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.7
    Confidence Interval (2-Sided) 95%
    4.7 to 18.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 19.9
    Confidence Interval (2-Sided) 95%
    12.5 to 27.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 27.2
    Confidence Interval (2-Sided) 95%
    20.5 to 33.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 21.6
    Confidence Interval (2-Sided) 95%
    13.2 to 30.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 19.5
    Confidence Interval (2-Sided) 95%
    11.1 to 27.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 22.6
    Confidence Interval (2-Sided) 95%
    15.8 to 29.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 16.6
    Confidence Interval (2-Sided) 95%
    8.1 to 25.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 13.8
    Confidence Interval (2-Sided) 95%
    5.3 to 22.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 21.4
    Confidence Interval (2-Sided) 95%
    14.6 to 28.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.3
    Confidence Interval (2-Sided) 95%
    3.7 to 20.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 18.1
    Confidence Interval (2-Sided) 95%
    9.7 to 26.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52
    Description The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
    Time Frame Weeks 2, 4, 12, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    7.2
    1.7%
    4.3
    2.1%
    10.0
    4.8%
    1.0
    0.2%
    Week 4
    16.6
    4%
    15.0
    7.2%
    19.5
    9.3%
    4.8
    1.2%
    Week 12
    39.7
    9.5%
    31.9
    15.4%
    29.5
    14%
    17.1
    4.1%
    Week 36
    52.6
    12.6%
    42.0
    20.3%
    43.3
    20.6%
    34.4
    8.3%
    Week 52
    53.4
    12.8%
    43.0
    20.8%
    46.2
    22%
    31.5
    7.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.3
    Confidence Interval (2-Sided) 95%
    3.4 to 9.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 3.4
    Confidence Interval (2-Sided) 95%
    0.1 to 6.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.0
    Confidence Interval (2-Sided) 95%
    4.5 to 13.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.8
    Confidence Interval (2-Sided) 95%
    7.4 to 16.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.2
    Confidence Interval (2-Sided) 95%
    4.5 to 15.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.7
    Confidence Interval (2-Sided) 95%
    8.6 to 20.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 22.6
    Confidence Interval (2-Sided) 95%
    16.4 to 28.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.8
    Confidence Interval (2-Sided) 95%
    7.1 to 22.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 12.5
    Confidence Interval (2-Sided) 95%
    4.9 to 20.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 18.3
    Confidence Interval (2-Sided) 95%
    11.4 to 25.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.056
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.7
    Confidence Interval (2-Sided) 95%
    -0.8 to 16.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 9.0
    Confidence Interval (2-Sided) 95%
    0.5 to 17.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 21.9
    Confidence Interval (2-Sided) 95%
    15.1 to 28.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 11.5
    Confidence Interval (2-Sided) 95%
    3.1 to 20.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 14.7
    Confidence Interval (2-Sided) 95%
    6.3 to 23.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52
    Description ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
    Time Frame Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 2
    20.8
    (21.42)
    17.8
    (20.07)
    20.9
    (23.19)
    8.9
    (14.95)
    Week 4
    34.1
    (27.78)
    27.6
    (24.81)
    29.4
    (27.86)
    17.2
    (21.43)
    Week 12
    52.6
    (29.91)
    46.1
    (31.46)
    48.6
    (30.50)
    34.3
    (28.07)
    Week 24
    62.8
    (28.40)
    58.1
    (30.19)
    59.7
    (29.35)
    49.0
    (29.46)
    Week 36
    65.8
    (28.50)
    58.7
    (30.99)
    62.1
    (28.12)
    57.3
    (29.16)
    Week 52
    69.6
    (27.38)
    63.6
    (29.19)
    67.4
    (26.60)
    57.1
    (29.59)
    23. Secondary Outcome
    Title Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52
    Description Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2.
    Time Frame Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Good Response
    66
    15.9%
    21
    10.1%
    35
    16.7%
    20
    4.8%
    Moderate Response
    199
    47.8%
    92
    44.4%
    88
    41.9%
    118
    28.4%
    No Response
    134
    32.2%
    86
    41.5%
    77
    36.7%
    258
    62%
    Good Response
    120
    28.8%
    45
    21.7%
    63
    30%
    45
    10.8%
    Moderate Response
    206
    49.5%
    104
    50.2%
    97
    46.2%
    161
    38.7%
    No Response
    77
    18.5%
    50
    24.2%
    42
    20%
    195
    46.9%
    Good Response
    230
    55.3%
    100
    48.3%
    98
    46.7%
    116
    27.9%
    Moderate Response
    130
    31.3%
    79
    38.2%
    77
    36.7%
    190
    45.7%
    No Response
    26
    6.3%
    16
    7.7%
    14
    6.7%
    74
    17.8%
    Good Response
    283
    68%
    127
    61.4%
    126
    60%
    186
    44.7%
    Moderate Response
    82
    19.7%
    55
    26.6%
    52
    24.8%
    153
    36.8%
    No Response
    9
    2.2%
    8
    3.9%
    5
    2.4%
    29
    7%
    Good Response
    276
    66.3%
    118
    57%
    124
    59%
    208
    50%
    Moderate Response
    64
    15.4%
    54
    26.1%
    51
    24.3%
    106
    25.5%
    No Response
    7
    1.7%
    5
    2.4%
    2
    1%
    7
    1.7%
    Good Response
    286
    68.8%
    123
    59.4%
    136
    64.8%
    194
    46.6%
    Moderate Response
    43
    10.3%
    43
    20.8%
    30
    14.3%
    102
    24.5%
    No Response
    3
    0.7%
    4
    1.9%
    3
    1.4%
    11
    2.6%
    24. Secondary Outcome
    Title Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52
    Description CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    39.5
    (12.77)
    39.2
    (12.69)
    40.0
    (12.63)
    40.2
    (12.50)
    Change at Week 2
    -13.6
    (12.05)
    -12.0
    (10.54)
    -13.9
    (12.53)
    -8.5
    (11.33)
    Change at Week 4
    -19.9
    (13.64)
    -17.8
    (12.06)
    -18.4
    (12.96)
    -13.3
    (12.61)
    Change at Week 12
    -27.8
    (13.60)
    -26.1
    (13.00)
    -27.5
    (13.55)
    -22.7
    (13.38)
    Change at Week 24
    -31.3
    (13.19)
    -30.0
    (13.32)
    -31.3
    (12.57)
    -28.2
    (13.43)
    Change at Week 36
    -32.2
    (13.37)
    -30.8
    (12.84)
    -32.7
    (12.16)
    -31.3
    (12.66)
    Change at Week 52
    -33.8
    (13.00)
    -31.9
    (12.22)
    -33.6
    (12.28)
    -31.2
    (13.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -7.3 to -4.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.4
    Confidence Interval (2-Sided) 95%
    -6.4 to -2.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.01
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -7.7 to -3.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.01
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -7.3
    Confidence Interval (2-Sided) 95%
    -8.9 to -5.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.83
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -7.3 to -3.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.02
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.7
    Confidence Interval (2-Sided) 95%
    -7.8 to -3.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.02
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.8
    Confidence Interval (2-Sided) 95%
    -7.3 to -4.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.72
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.4
    Confidence Interval (2-Sided) 95%
    -6.1 to -2.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.88
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.1
    Confidence Interval (2-Sided) 95%
    -6.8 to -3.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.88
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.1
    Confidence Interval (2-Sided) 95%
    -5.3 to -2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.61
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.3 to -1.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.9
    Confidence Interval (2-Sided) 95%
    -4.4 to -1.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.2
    Confidence Interval (2-Sided) 95%
    -3.4 to -1.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.59
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.36
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -2.0 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.3 to -0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.72
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.3
    Confidence Interval (2-Sided) 95%
    -4.5 to -2.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.7 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.69
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -3.7 to -1.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.69
    Estimation Comments
    25. Secondary Outcome
    Title Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52
    Description SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 2, 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    41.3
    (13.41)
    41.0
    (13.53)
    41.8
    (13.09)
    41.9
    (13.39)
    Change at Week 2
    -14.9
    (12.45)
    -12.9
    (10.84)
    -15.0
    (12.82)
    -8.6
    (11.49)
    Change at Week 4
    -21.3
    (14.17)
    -19.0
    (12.58)
    -19.6
    (13.38)
    -13.7
    (12.83)
    Change at Week 12
    -29.2
    (14.05)
    -27.1
    (13.59)
    -28.6
    (14.02)
    -23.5
    (13.82)
    Change at Week 24
    -32.7
    (13.83)
    -31.1
    (14.09)
    -32.7
    (13.14)
    -29.0
    (14.09)
    Change at Week 36
    -33.5
    (14.02)
    -32.1
    (13.61)
    -33.9
    (12.67)
    -32.3
    (13.47)
    Change at Week 52
    -35.2
    (13.68)
    -33.0
    (13.12)
    -35.0
    (12.69)
    -32.0
    (14.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.8
    Confidence Interval (2-Sided) 95%
    -8.5 to -5.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.3
    Confidence Interval (2-Sided) 95%
    -7.3 to -3.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.04
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.7
    Confidence Interval (2-Sided) 95%
    -8.8 to -4.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.03
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -8.3
    Confidence Interval (2-Sided) 95%
    -9.9 to -6.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.2
    Confidence Interval (2-Sided) 95%
    -8.2 to -4.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.04
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -8.5 to -4.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.04
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -6.5
    Confidence Interval (2-Sided) 95%
    -8.0 to -5.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.8
    Confidence Interval (2-Sided) 95%
    -6.5 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.90
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -5.6
    Confidence Interval (2-Sided) 95%
    -7.4 to -3.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.90
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -4.6
    Confidence Interval (2-Sided) 95%
    -5.9 to -3.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.64
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.1
    Confidence Interval (2-Sided) 95%
    -4.6 to -1.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.4
    Confidence Interval (2-Sided) 95%
    -4.9 to -1.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.6
    Confidence Interval (2-Sided) 95%
    -3.8 to -1.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.61
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.4 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.1
    Confidence Interval (2-Sided) 95%
    -3.6 to -0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.75
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -3.8
    Confidence Interval (2-Sided) 95%
    -5.0 to -2.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.60
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.021
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.1 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.73
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.3 to -1.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.73
    Estimation Comments
    26. Secondary Outcome
    Title Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52
    Description Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC).
    Time Frame Baseline; Weeks 24, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 24: Change in mTSS ≤ 0.5
    89.6
    21.5%
    87.0
    42%
    89.6
    42.7%
    82.0
    19.7%
    Week 24: Change in mTSS ≤ 0
    80.6
    19.4%
    76.6
    37%
    82.7
    39.4%
    72.5
    17.4%
    Week 24: Change in mTSS ≤ SDC (1.53)
    95.2
    22.9%
    93.5
    45.2%
    96.0
    45.7%
    91.6
    22%
    Week 52: Change in mTSS ≤ 0.5
    88.1
    21.2%
    85.8
    41.4%
    84.3
    40.1%
    77.9
    18.7%
    Week 52: Change in mTSS ≤ 0
    80.6
    19.4%
    76.1
    36.8%
    77.1
    36.7%
    70.6
    17%
    Week 52: Change in mTSS ≤ SDC (1.77)
    94.2
    22.6%
    94.9
    45.8%
    89.2
    42.5%
    86.7
    20.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.6
    Confidence Interval (2-Sided) 95%
    2.2 to 12.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.9
    Confidence Interval (2-Sided) 95%
    -1.8 to 11.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.6
    Confidence Interval (2-Sided) 95%
    1.1 to 14.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 8.1
    Confidence Interval (2-Sided) 95%
    1.6 to 14.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.33
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.2
    Confidence Interval (2-Sided) 95%
    -3.9 to 12.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.2
    Confidence Interval (2-Sided) 95%
    2.5 to 17.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.074
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 3.6
    Confidence Interval (2-Sided) 95%
    -0.3 to 7.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.49
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 1.9
    Confidence Interval (2-Sided) 95%
    -3.1 to 6.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS <= SDC (1.53)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.075
    Comments P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 4.4
    Confidence Interval (2-Sided) 95%
    -0.2 to 8.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.2
    Confidence Interval (2-Sided) 95%
    4.3 to 16.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.9
    Confidence Interval (2-Sided) 95%
    0.7 to 15.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= 0.5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.100
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.5
    Confidence Interval (2-Sided) 95%
    -1.1 to 14.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 10.0
    Confidence Interval (2-Sided) 95%
    3.2 to 16.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.25
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 5.5
    Confidence Interval (2-Sided) 95%
    -2.9 to 14.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= 0
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 6.5
    Confidence Interval (2-Sided) 95%
    -2.0 to 15.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 7.5
    Confidence Interval (2-Sided) 95%
    2.8 to 12.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 8.2
    Confidence Interval (2-Sided) 95%
    2.9 to 13.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS <= SDC (1.77)
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.47
    Comments P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Difference in Response Rates
    Estimated Value 2.5
    Confidence Interval (2-Sided) 95%
    -3.9 to 8.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52
    Description The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    40.6
    (8.04)
    39.2
    (8.86)
    39.6
    (8.46)
    37.0
    (8.13)
    Week 12
    45.0
    (8.42)
    42.9
    (9.71)
    42.7
    (9.90)
    40.9
    (8.10)
    Week 24
    46.3
    (8.16)
    44.8
    (9.39)
    44.1
    (9.42)
    43.0
    (8.36)
    Week 36
    46.6
    (8.17)
    45.2
    (9.42)
    45.0
    (8.89)
    44.4
    (8.39)
    Week 52
    47.4
    (8.35)
    45.6
    (9.02)
    45.9
    (9.40)
    44.5
    (8.32)
    28. Secondary Outcome
    Title Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52
    Description The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
    Time Frame Baseline; Weeks 4, 12, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    33.9
    (7.48)
    33.7
    (8.00)
    33.6
    (7.70)
    33.3
    (7.28)
    Change at Week 4
    6.8
    (6.86)
    5.3
    (6.90)
    5.9
    (7.53)
    3.8
    (6.38)
    Change at Week 12
    11.2
    (8.66)
    9.1
    (8.82)
    8.9
    (9.17)
    7.6
    (7.64)
    Change at Week 36
    12.4
    (9.30)
    11.7
    (8.52)
    11.2
    (8.54)
    11.3
    (9.04)
    Change at Week 52
    13.4
    (9.62)
    12.0
    (8.47)
    11.9
    (9.22)
    11.2
    (9.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.2
    Confidence Interval (2-Sided) 95%
    2.4 to 4.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.45
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    0.7 to 2.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.55
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.3
    Confidence Interval (2-Sided) 95%
    1.3 to 3.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.55
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.7
    Confidence Interval (2-Sided) 95%
    2.7 to 4.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    0.5 to 3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.66
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.2 to 2.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.66
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    0.6 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.59
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.6
    Confidence Interval (2-Sided) 95%
    -0.8 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.59
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.4
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.72
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.8
    Confidence Interval (2-Sided) 95%
    1.6 to 4.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.62
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -0.3 to 2.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.071
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    -0.17 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    29. Secondary Outcome
    Title SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52
    Description The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    48.7
    (9.73)
    46.9
    (10.42)
    47.5
    (10.46)
    45.5
    (11.38)
    Week 12
    49.9
    (9.49)
    49.2
    (9.99)
    48.8
    (10.85)
    48.1
    (10.26)
    Week 24
    50.1
    (9.61)
    50.1
    (10.34)
    49.2
    (10.11)
    49.4
    (10.25)
    Week 36
    51.1
    (9.38)
    50.6
    (10.26)
    49.1
    (9.61)
    49.9
    (10.20)
    Week 52
    50.9
    (9.32)
    50.0
    (10.08)
    49.7
    (10.00)
    50.2
    (9.64)
    30. Secondary Outcome
    Title Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52
    Description The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    44.6
    (10.60)
    43.2
    (11.47)
    43.1
    (11.27)
    43.5
    (11.50)
    Change at Week 4
    4.1
    (9.32)
    3.6
    (8.93)
    4.5
    (9.59)
    1.9
    (9.22)
    Change at Week 12
    5.3
    (10.00)
    5.7
    (10.04)
    5.5
    (10.87)
    4.5
    (10.26)
    Change at Week 24
    5.4
    (10.45)
    6.6
    (10.89)
    5.8
    (11.26)
    6.0
    (10.95)
    Change at Week 36
    6.5
    (10.68)
    7.3
    (11.17)
    5.4
    (11.66)
    6.2
    (10.96)
    Change at Week 52
    6.2
    (10.74)
    6.8
    (11.47)
    6.1
    (11.26)
    6.5
    (11.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.7
    Confidence Interval (2-Sided) 95%
    1.6 to 3.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.032
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.1 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.70
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    1.0 to 3.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.70
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    0.2 to 2.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.60
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.065
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    -0.1 to 2.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    -0.4 to 2.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.74
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.73
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -1.0 to 1.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.64
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.37
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.8 to 2.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.83
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.7 to 1.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.073
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -0.1 to 2.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.66
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.090
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.4
    Confidence Interval (2-Sided) 95%
    -0.2 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.80
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.68
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.9 to 1.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.30
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.6 to 2.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.69
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -1.3 to 1.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.95
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.7 to 1.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    31. Secondary Outcome
    Title FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52
    Description FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    35.2
    (9.82)
    34.1
    (10.75)
    34.2
    (10.52)
    31.4
    (10.87)
    Week 12
    38.1
    (10.21)
    36.6
    (11.26)
    36.9
    (11.16)
    35.3
    (10.23)
    Week 24
    39.1
    (10.13)
    38.7
    (10.11)
    37.9
    (10.76)
    37.3
    (10.62)
    Week 36
    39.8
    (9.58)
    38.9
    (10.19)
    38.8
    (10.17)
    38.1
    (9.86)
    Week 52
    40.2
    (9.36)
    38.7
    (9.88)
    39.7
    (10.96)
    38.4
    (9.91)
    32. Secondary Outcome
    Title Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52
    Description FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
    Time Frame Baseline; Weeks 4, 12, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    28.3
    (10.93)
    27.3
    (11.92)
    27.3
    (10.90)
    27.1
    (10.72)
    Change at Week 4
    7.0
    (9.46)
    6.7
    (9.64)
    6.8
    (9.94)
    4.3
    (9.24)
    Change at Week 12
    9.8
    (11.20)
    9.2
    (11.21)
    9.4
    (10.57)
    8.1
    (10.09)
    Change at Week 36
    11.3
    (11.21)
    11.9
    (11.53)
    10.9
    (10.81)
    11.1
    (10.91)
    Change at Week 52
    11.7
    (11.52)
    11.9
    (12.29)
    11.5
    (11.17)
    11.3
    (11.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.2
    Confidence Interval (2-Sided) 95%
    2.1 to 4.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.5
    Confidence Interval (2-Sided) 95%
    1.1 to 3.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.70
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.7
    Confidence Interval (2-Sided) 95%
    1.3 to 4.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.2
    Confidence Interval (2-Sided) 95%
    1.0 to 3.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.64
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.13
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -0.4 to 2.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.032
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    0.1 to 3.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.79
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.028
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.5
    Confidence Interval (2-Sided) 95%
    0.2 to 2.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -0.4 to 2.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.9 to 2.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    0.3 to 3.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.27
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    -0.7 to 2.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.86
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.15
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.2
    Confidence Interval (2-Sided) 95%
    -0.5 to 2.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.87
    Estimation Comments
    33. Secondary Outcome
    Title Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52
    Description The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    No Problems
    161
    38.7%
    66
    31.9%
    81
    38.6%
    104
    25%
    Slight Problems
    149
    35.8%
    68
    32.9%
    56
    26.7%
    135
    32.5%
    Moderate Problems
    82
    19.7%
    50
    24.2%
    38
    18.1%
    116
    27.9%
    Severe Problems
    13
    3.1%
    17
    8.2%
    20
    9.5%
    54
    13%
    Extreme Problems
    1
    0.2%
    1
    0.5%
    6
    2.9%
    1
    0.2%
    No Problems
    198
    47.6%
    87
    42%
    86
    41%
    138
    33.2%
    Slight Problems
    135
    32.5%
    56
    27.1%
    60
    28.6%
    135
    32.5%
    Moderate Problems
    41
    9.9%
    36
    17.4%
    27
    12.9%
    91
    21.9%
    Severe Problems
    12
    2.9%
    17
    8.2%
    14
    6.7%
    20
    4.8%
    Extreme Problems
    4
    1%
    0
    0%
    5
    2.4%
    4
    1%
    No Problems
    208
    50%
    92
    44.4%
    95
    45.2%
    152
    36.5%
    Slight Problems
    116
    27.9%
    55
    26.6%
    50
    23.8%
    135
    32.5%
    Moderate Problems
    46
    11.1%
    36
    17.4%
    24
    11.4%
    63
    15.1%
    Severe Problems
    5
    1.2%
    9
    4.3%
    13
    6.2%
    16
    3.8%
    Extreme Problems
    2
    0.5%
    0
    0%
    2
    1%
    4
    1%
    No Problems
    216
    51.9%
    93
    44.9%
    98
    46.7%
    152
    36.5%
    Slight Problems
    96
    23.1%
    60
    29%
    46
    21.9%
    135
    32.5%
    Moderate Problems
    48
    11.5%
    30
    14.5%
    27
    12.9%
    51
    12.3%
    Severe Problems
    5
    1.2%
    5
    2.4%
    8
    3.8%
    16
    3.8%
    Extreme Problems
    0
    0%
    0
    0%
    1
    0.5%
    2
    0.5%
    No Problems
    217
    52.2%
    91
    44%
    93
    44.3%
    156
    37.5%
    Slight Problems
    92
    22.1%
    50
    24.2%
    47
    22.4%
    108
    26%
    Moderate Problems
    28
    6.7%
    29
    14%
    21
    10%
    54
    13%
    Severe Problems
    9
    2.2%
    6
    2.9%
    10
    4.8%
    15
    3.6%
    Extreme Problems
    1
    0.2%
    0
    0%
    3
    1.4%
    1
    0.2%
    No Problems
    214
    51.4%
    99
    47.8%
    102
    48.6%
    143
    34.4%
    Slight Problems
    142
    34.1%
    63
    30.4%
    50
    23.8%
    141
    33.9%
    Moderate Problems
    42
    10.1%
    28
    13.5%
    38
    18.1%
    96
    23.1%
    Severe Problems
    7
    1.7%
    9
    4.3%
    10
    4.8%
    29
    7%
    Extreme Problems
    1
    0.2%
    3
    1.4%
    1
    0.5%
    1
    0.2%
    No Problems
    277
    66.6%
    113
    54.6%
    111
    52.9%
    190
    45.7%
    Slight Problems
    85
    20.4%
    55
    26.6%
    55
    26.2%
    129
    31%
    Moderate Problems
    19
    4.6%
    22
    10.6%
    21
    10%
    54
    13%
    Severe Problems
    6
    1.4%
    5
    2.4%
    4
    1.9%
    13
    3.1%
    Extreme Problems
    3
    0.7%
    1
    0.5%
    1
    0.5%
    2
    0.5%
    No Problems
    283
    68%
    128
    61.8%
    112
    53.3%
    222
    53.4%
    Slight Problems
    73
    17.5%
    42
    20.3%
    52
    24.8%
    95
    22.8%
    Moderate Problems
    16
    3.8%
    20
    9.7%
    17
    8.1%
    46
    11.1%
    Severe Problems
    1
    0.2%
    2
    1%
    3
    1.4%
    5
    1.2%
    Extreme Problems
    4
    1%
    0
    0%
    0
    0%
    2
    0.5%
    No Problems
    271
    65.1%
    122
    58.9%
    121
    57.6%
    224
    53.8%
    Slight Problems
    70
    16.8%
    44
    21.3%
    41
    19.5%
    93
    22.4%
    Moderate Problems
    20
    4.8%
    21
    10.1%
    16
    7.6%
    31
    7.5%
    Severe Problems
    3
    0.7%
    1
    0.5%
    1
    0.5%
    5
    1.2%
    Extreme Problems
    1
    0.2%
    0
    0%
    1
    0.5%
    3
    0.7%
    No Problems
    268
    64.4%
    117
    56.5%
    117
    55.7%
    208
    50%
    Slight Problems
    60
    14.4%
    36
    17.4%
    36
    17.1%
    84
    20.2%
    Moderate Problems
    13
    3.1%
    21
    10.1%
    16
    7.6%
    35
    8.4%
    Severe Problems
    5
    1.2%
    2
    1%
    4
    1.9%
    6
    1.4%
    Extreme Problems
    1
    0.2%
    0
    0%
    1
    0.5%
    1
    0.2%
    No Problems
    118
    28.4%
    50
    24.2%
    54
    25.7%
    80
    19.2%
    Slight Problems
    180
    43.3%
    86
    41.5%
    81
    38.6%
    153
    36.8%
    Moderate Problems
    90
    21.6%
    47
    22.7%
    49
    23.3%
    122
    29.3%
    Severe Problems
    16
    3.8%
    19
    9.2%
    14
    6.7%
    49
    11.8%
    Extreme Problems
    2
    0.5%
    0
    0%
    3
    1.4%
    6
    1.4%
    No Problems
    185
    44.5%
    78
    37.7%
    83
    39.5%
    101
    24.3%
    Slight Problems
    148
    35.6%
    65
    31.4%
    61
    29%
    179
    43%
    Moderate Problems
    44
    10.6%
    42
    20.3%
    35
    16.7%
    85
    20.4%
    Severe Problems
    11
    2.6%
    9
    4.3%
    11
    5.2%
    19
    4.6%
    Extreme Problems
    2
    0.5%
    2
    1%
    2
    1%
    4
    1%
    No Problems
    188
    45.2%
    92
    44.4%
    83
    39.5%
    142
    34.1%
    Slight Problems
    135
    32.5%
    60
    29%
    63
    30%
    147
    35.3%
    Moderate Problems
    43
    10.3%
    31
    15%
    30
    14.3%
    64
    15.4%
    Severe Problems
    8
    1.9%
    9
    4.3%
    8
    3.8%
    13
    3.1%
    Extreme Problems
    3
    0.7%
    0
    0%
    0
    0%
    4
    1%
    No Problems
    199
    47.8%
    86
    41.5%
    92
    43.8%
    158
    38%
    Slight Problems
    119
    28.6%
    61
    29.5%
    51
    24.3%
    134
    32.2%
    Moderate Problems
    42
    10.1%
    37
    17.9%
    31
    14.8%
    50
    12%
    Severe Problems
    5
    1.2%
    4
    1.9%
    3
    1.4%
    12
    2.9%
    Extreme Problems
    0
    0%
    0
    0%
    3
    1.4%
    2
    0.5%
    No Problems
    203
    48.8%
    84
    40.6%
    92
    43.8%
    147
    35.3%
    Slight Problems
    106
    25.5%
    62
    30%
    48
    22.9%
    125
    30%
    Moderate Problems
    31
    7.5%
    22
    10.6%
    27
    12.9%
    50
    12%
    Severe Problems
    7
    1.7%
    7
    3.4%
    5
    2.4%
    10
    2.4%
    Extreme Problems
    0
    0%
    1
    0.5%
    2
    1%
    2
    0.5%
    No Problems
    45
    10.8%
    23
    11.1%
    21
    10%
    18
    4.3%
    Slight Problems
    208
    50%
    85
    41.1%
    91
    43.3%
    131
    31.5%
    Moderate Problems
    132
    31.7%
    73
    35.3%
    60
    28.6%
    173
    41.6%
    Severe Problems
    21
    5%
    19
    9.2%
    26
    12.4%
    78
    18.8%
    Extreme Problems
    0
    0%
    2
    1%
    3
    1.4%
    10
    2.4%
    No Problems
    93
    22.4%
    35
    16.9%
    38
    18.1%
    41
    9.9%
    Slight Problems
    202
    48.6%
    96
    46.4%
    81
    38.6%
    167
    40.1%
    Moderate Problems
    83
    20%
    47
    22.7%
    53
    25.2%
    143
    34.4%
    Severe Problems
    12
    2.9%
    15
    7.2%
    16
    7.6%
    35
    8.4%
    Extreme Problems
    0
    0%
    3
    1.4%
    4
    1.9%
    2
    0.5%
    No Problems
    110
    26.4%
    46
    22.2%
    40
    19%
    44
    10.6%
    Slight Problems
    182
    43.8%
    91
    44%
    93
    44.3%
    206
    49.5%
    Moderate Problems
    75
    18%
    46
    22.2%
    42
    20%
    98
    23.6%
    Severe Problems
    9
    2.2%
    9
    4.3%
    7
    3.3%
    22
    5.3%
    Extreme Problems
    1
    0.2%
    0
    0%
    2
    1%
    0
    0%
    No Problems
    102
    24.5%
    43
    20.8%
    39
    18.6%
    57
    13.7%
    Slight Problems
    188
    45.2%
    90
    43.5%
    87
    41.4%
    195
    46.9%
    Moderate Problems
    68
    16.3%
    41
    19.8%
    44
    21%
    85
    20.4%
    Severe Problems
    6
    1.4%
    14
    6.8%
    7
    3.3%
    18
    4.3%
    Extreme Problems
    1
    0.2%
    0
    0%
    3
    1.4%
    1
    0.2%
    No Problems
    108
    26%
    46
    22.2%
    49
    23.3%
    63
    15.1%
    Slight Problems
    169
    40.6%
    82
    39.6%
    88
    41.9%
    168
    40.4%
    Moderate Problems
    59
    14.2%
    40
    19.3%
    25
    11.9%
    80
    19.2%
    Severe Problems
    11
    2.6%
    8
    3.9%
    9
    4.3%
    22
    5.3%
    Extreme Problems
    0
    0%
    0
    0%
    3
    1.4%
    1
    0.2%
    No Problems
    221
    53.1%
    101
    48.8%
    94
    44.8%
    159
    38.2%
    Slight Problems
    126
    30.3%
    58
    28%
    64
    30.5%
    148
    35.6%
    Moderate Problems
    53
    12.7%
    33
    15.9%
    35
    16.7%
    73
    17.5%
    Severe Problems
    6
    1.4%
    10
    4.8%
    6
    2.9%
    25
    6%
    Extreme Problems
    0
    0%
    0
    0%
    2
    1%
    5
    1.2%
    No Problems
    233
    56%
    104
    50.2%
    106
    50.5%
    198
    47.6%
    Slight Problems
    114
    27.4%
    62
    30%
    58
    27.6%
    125
    30%
    Moderate Problems
    28
    6.7%
    19
    9.2%
    17
    8.1%
    49
    11.8%
    Severe Problems
    14
    3.4%
    9
    4.3%
    10
    4.8%
    15
    3.6%
    Extreme Problems
    1
    0.2%
    2
    1%
    1
    0.5%
    1
    0.2%
    No Problems
    236
    56.7%
    117
    56.5%
    103
    49%
    219
    52.6%
    Slight Problems
    97
    23.3%
    47
    22.7%
    64
    30.5%
    93
    22.4%
    Moderate Problems
    32
    7.7%
    25
    12.1%
    11
    5.2%
    42
    10.1%
    Severe Problems
    9
    2.2%
    3
    1.4%
    6
    2.9%
    14
    3.4%
    Extreme Problems
    3
    0.7%
    0
    0%
    0
    0%
    2
    0.5%
    No Problems
    233
    56%
    119
    57.5%
    103
    49%
    194
    46.6%
    Slight Problems
    99
    23.8%
    50
    24.2%
    56
    26.7%
    116
    27.9%
    Moderate Problems
    31
    7.5%
    13
    6.3%
    17
    8.1%
    32
    7.7%
    Severe Problems
    2
    0.5%
    5
    2.4%
    3
    1.4%
    12
    2.9%
    Extreme Problems
    0
    0%
    1
    0.5%
    1
    0.5%
    2
    0.5%
    No Problems
    222
    53.4%
    113
    54.6%
    106
    50.5%
    182
    43.8%
    Slight Problems
    94
    22.6%
    40
    19.3%
    43
    20.5%
    100
    24%
    Moderate Problems
    26
    6.3%
    18
    8.7%
    20
    9.5%
    45
    10.8%
    Severe Problems
    5
    1.2%
    5
    2.4%
    3
    1.4%
    5
    1.2%
    Extreme Problems
    0
    0%
    0
    0%
    2
    1%
    2
    0.5%
    34. Secondary Outcome
    Title EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
    Description EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    65
    (18.7)
    61
    (21.6)
    62
    (20.0)
    56
    (21.2)
    Week 12
    69
    (21.3)
    67
    (22.9)
    66
    (22.7)
    64
    (20.7)
    Week 24
    73
    (21.0)
    72
    (19.6)
    68
    (22.4)
    69
    (21.3)
    Week 36
    73
    (22.1)
    71
    (21.8)
    69
    (21.1)
    68
    (22.8)
    Week 52
    75
    (21.7)
    72
    (22.1)
    71
    (23.7)
    71
    (21.2)
    35. Secondary Outcome
    Title Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
    Description The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    50
    (22.0)
    50
    (24.6)
    51
    (22.5)
    50
    (22.1)
    Change at Week 4
    16
    (25.0)
    10
    (24.6)
    11
    (22.4)
    7
    (25.0)
    Change at Week 12
    19
    (29.8)
    17
    (28.0)
    15
    (26.1)
    14
    (27.7)
    Change at Week 24
    24
    (28.1)
    21
    (27.7)
    17
    (29.0)
    19
    (28.8)
    Change at Week 36
    23
    (29.7)
    21
    (28.6)
    18
    (28.8)
    19
    (29.8)
    Change at Week 52
    26
    (31.1)
    22
    (31.5)
    20
    (30.1)
    22
    (30.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 9.0
    Confidence Interval (2-Sided) 95%
    6.0 to 12.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.3
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    1.0 to 8.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 6.0
    Confidence Interval (2-Sided) 95%
    3.0 to 9.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    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
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.089
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.0
    Confidence Interval (2-Sided) 95%
    -0.0 to 7.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -1.0 to 6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.9
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    1.0 to 7.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.5
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 4.0
    Confidence Interval (2-Sided) 95%
    0.0 to 7.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -4.0 to 3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.8
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    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
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 6.0
    Confidence Interval (2-Sided) 95%
    2.0 to 9.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.078
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 3.0
    Confidence Interval (2-Sided) 95%
    -0.0 to 7.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -2.0 to 6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 5.0
    Confidence Interval (2-Sided) 95%
    2.0 to 8.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.7
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.45
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -3.0 to 6.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
    Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.85
    Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 0.0
    Confidence Interval (2-Sided) 95%
    -4.0 to 5.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.1
    Estimation Comments
    36. Secondary Outcome
    Title Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    10.1
    (23.95)
    15.4
    (30.46)
    9.2
    (21.88)
    16.0
    (30.49)
    Week 12
    6.7
    (19.11)
    7.3
    (18.29)
    12.6
    (24.42)
    11.3
    (25.59)
    Week 24
    6.4
    (19.93)
    5.7
    (13.96)
    12.4
    (23.14)
    5.1
    (14.21)
    Week 36
    5.5
    (15.78)
    7.0
    (17.90)
    11.5
    (25.28)
    5.6
    (16.90)
    Week 52
    4.6
    (14.62)
    8.5
    (20.70)
    9.8
    (22.21)
    6.4
    (19.84)
    37. Secondary Outcome
    Title WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    29.6
    (24.21)
    29.4
    (27.76)
    33.9
    (24.10)
    45.3
    (26.04)
    Week 12
    22.6
    (23.43)
    23.6
    (24.85)
    26.0
    (24.78)
    32.5
    (24.31)
    Week 24
    17.9
    (18.95)
    18.1
    (19.40)
    23.2
    (24.70)
    23.3
    (21.18)
    Week 36
    15.5
    (18.38)
    16.3
    (20.31)
    20.9
    (24.04)
    22.7
    (24.10)
    Week 52
    14.5
    (18.08)
    19.6
    (22.32)
    16.5
    (23.08)
    18.3
    (16.95)
    38. Secondary Outcome
    Title WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    32.8
    (25.79)
    32.3
    (29.18)
    37.0
    (25.87)
    48.6
    (27.40)
    Week 12
    25.1
    (26.42)
    26.7
    (28.11)
    31.4
    (28.43)
    35.5
    (26.13)
    Week 24
    20.2
    (22.36)
    22.4
    (22.92)
    29.3
    (28.98)
    26.2
    (23.45)
    Week 36
    18.8
    (22.09)
    20.9
    (23.34)
    24.5
    (28.11)
    25.0
    (25.89)
    Week 52
    17.2
    (21.61)
    22.9
    (25.21)
    21.2
    (27.26)
    20.7
    (18.67)
    39. Secondary Outcome
    Title WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
    Time Frame Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Week 4
    40.4
    (25.52)
    46.8
    (27.82)
    45.4
    (25.65)
    51.6
    (24.73)
    Week 12
    30.6
    (25.53)
    36.1
    (26.77)
    34.7
    (27.29)
    41.1
    (24.75)
    Week 24
    26.5
    (23.32)
    29.5
    (26.02)
    32.3
    (26.92)
    32.1
    (24.44)
    Week 36
    23.5
    (22.54)
    29.7
    (27.03)
    29.0
    (26.08)
    31.8
    (25.55)
    Week 52
    22.5
    (22.80)
    28.2
    (26.54)
    25.6
    (25.19)
    28.8
    (23.81)
    40. Secondary Outcome
    Title Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    12.8
    (24.29)
    20.1
    (32.36)
    13.5
    (26.35)
    15.6
    (28.79)
    Change at Week 4
    -1.5
    (25.68)
    -3.3
    (24.44)
    -4.0
    (21.08)
    -1.3
    (23.73)
    Change at Week 12
    -4.9
    (25.11)
    -11.0
    (32.65)
    -2.3
    (23.52)
    -5.2
    (29.01)
    Change at Week 24
    -4.8
    (28.91)
    -15.5
    (34.51)
    -3.1
    (28.77)
    -10.6
    (29.08)
    Change at Week 36
    -6.7
    (28.20)
    -16.4
    (35.63)
    -4.1
    (26.83)
    -7.9
    (29.99)
    Change at Week 52
    -4.8
    (23.27)
    -15.7
    (32.72)
    -2.8
    (29.12)
    -6.7
    (31.63)
    41. Secondary Outcome
    Title Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    47.3
    (26.32)
    49.0
    (28.45)
    52.1
    (25.81)
    53.6
    (27.12)
    Change at Week 4
    -17.8
    (25.34)
    -19.8
    (27.49)
    -18.3
    (28.58)
    -7.4
    (20.55)
    Change at Week 12
    -25.6
    (27.09)
    -28.4
    (29.39)
    -26.0
    (24.70)
    -20.7
    (27.83)
    Change at Week 24
    -27.1
    (26.77)
    -32.9
    (28.20)
    -27.9
    (27.06)
    -28.3
    (29.06)
    Change at Week 36
    -29.1
    (24.99)
    -33.8
    (27.99)
    -30.3
    (29.38)
    -28.8
    (31.92)
    Change at Week 52
    -32.3
    (26.81)
    -32.7
    (31.75)
    -33.3
    (29.25)
    -31.5
    (28.23)
    42. Secondary Outcome
    Title Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    50.8
    (27.28)
    51.6
    (30.10)
    54.4
    (25.60)
    56.1
    (28.00)
    Change at Week 4
    -17.6
    (26.21)
    -19.0
    (29.43)
    -17.6
    (28.69)
    -6.4
    (22.27)
    Change at Week 12
    -26.3
    (28.85)
    -27.5
    (30.53)
    -23.5
    (26.01)
    -20.1
    (28.63)
    Change at Week 24
    -28.5
    (27.71)
    -31.3
    (30.04)
    -24.7
    (29.61)
    -27.9
    (29.31)
    Change at Week 36
    -29.3
    (26.76)
    -33.1
    (31.56)
    -29.1
    (31.79)
    -29.2
    (32.72)
    Change at Week 52
    -33.0
    (28.74)
    -33.5
    (32.34)
    -30.6
    (31.24)
    -30.8
    (28.76)
    43. Secondary Outcome
    Title Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
    Description The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
    Time Frame Baseline; Weeks 4, 12, 24, 36, and 52

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    Measure Participants 416 207 210 416
    Baseline
    60.2
    (23.36)
    62.8
    (23.10)
    63.3
    (24.37)
    64.0
    (22.59)
    Change at Week 4
    -19.9
    (24.07)
    -15.8
    (23.90)
    -17.8
    (27.11)
    -12.4
    (23.80)
    Change at Week 12
    -29.4
    (27.15)
    -26.4
    (26.19)
    -28.7
    (27.80)
    -22.7
    (25.32)
    Change at Week 24
    -33.1
    (26.84)
    -33.2
    (26.97)
    -31.2
    (28.01)
    -31.5
    (27.80)
    Change at Week 36
    -35.6
    (26.52)
    -33.8
    (26.48)
    -34.1
    (28.26)
    -32.1
    (28.47)
    Change at Week 52
    -36.7
    (27.11)
    -35.4
    (28.32)
    -36.7
    (28.37)
    -34.2
    (28.83)

    Adverse Events

    Time Frame First dose date up to last dose date (Maximum: 56 weeks) plus 30 days
    Adverse Event Reporting Description The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
    All Cause Mortality
    Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/416 (0.7%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Serious Adverse Events
    Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 26/416 (6.3%) 13/207 (6.3%) 17/210 (8.1%) 28/416 (6.7%)
    Blood and lymphatic system disorders
    Bone marrow failure 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Leukocytosis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Pancytopenia 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Thrombocytosis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Cardiac disorders
    Acute myocardial infarction 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Atrial fibrillation 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 1/416 (0.2%)
    Lupus myocarditis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Myocardial infarction 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Supraventricular tachycardia 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Congenital, familial and genetic disorders
    Atrial septal defect 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Endocrine disorders
    Hyperthyroidism 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Gastrointestinal disorders
    Abdominal pain upper 2/416 (0.5%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Appendiceal mucocoele 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Diverticular perforation 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Gastritis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Gastrointestinal fistula 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Gastrointestinal haemorrhage 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Megacolon 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Proctitis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Small intestinal obstruction 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Upper gastrointestinal haemorrhage 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    General disorders
    Chest pain 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Pyrexia 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Systemic inflammatory response syndrome 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Infections and infestations
    Abdominal hernia infection 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Appendicitis 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Arthritis infective 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Bronchitis 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 1/416 (0.2%)
    Herpes zoster 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Lower respiratory tract infection 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Lymphangitis 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Pneumocystis jirovecii pneumonia 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Pneumonia 4/416 (1%) 1/207 (0.5%) 0/210 (0%) 1/416 (0.2%)
    Pneumonia bacterial 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Pneumonia cryptococcal 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Pulmonary sepsis 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Pyelonephritis 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Pyonephrosis 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Sepsis 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 1/416 (0.2%)
    Septic shock 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Skin infection 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Tracheobronchitis 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Femur fracture 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Incisional hernia, obstructive 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Subdural haematoma 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Investigations
    White blood cell count decreased 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Hypertriglyceridaemia 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Hypoglycaemia 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Back pain 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Intervertebral disc disorder 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Intervertebral disc protrusion 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Osteoarthritis 0/416 (0%) 2/207 (1%) 1/210 (0.5%) 1/416 (0.2%)
    Pathological fracture 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Spinal osteoarthritis 0/416 (0%) 2/207 (1%) 1/210 (0.5%) 0/416 (0%)
    Spinal stenosis 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Giant cell tumour of tendon sheath 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Ovarian adenoma 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Prostate cancer 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Small cell lung cancer 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Squamous cell carcinoma 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Nervous system disorders
    Cerebral amyloid angiopathy 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Cerebral artery occlusion 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Cervical radiculopathy 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Facial paralysis 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Haemorrhagic stroke 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Intracranial aneurysm 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Ischaemic stroke 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Subarachnoid haemorrhage 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Vertebral artery aneurysm 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Psychiatric disorders
    Depression 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Renal and urinary disorders
    Nephrolithiasis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/416 (0%) 1/207 (0.5%) 0/210 (0%) 0/416 (0%)
    Bronchiectasis 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Emphysema 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Interstitial lung disease 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Lung consolidation 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Pleurisy 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Pneumonitis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Pulmonary embolism 0/416 (0%) 0/207 (0%) 0/210 (0%) 2/416 (0.5%)
    Skin and subcutaneous tissue disorders
    Prurigo 0/416 (0%) 0/207 (0%) 1/210 (0.5%) 0/416 (0%)
    Vascular disorders
    Deep vein thrombosis 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Hypertension 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Rheumatoid vasculitis 1/416 (0.2%) 0/207 (0%) 0/210 (0%) 0/416 (0%)
    Varicose vein 0/416 (0%) 0/207 (0%) 0/210 (0%) 1/416 (0.2%)
    Other (Not Including Serious) Adverse Events
    Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 179/416 (43%) 88/207 (42.5%) 78/210 (37.1%) 164/416 (39.4%)
    Gastrointestinal disorders
    Diarrhoea 17/416 (4.1%) 12/207 (5.8%) 6/210 (2.9%) 21/416 (5%)
    Nausea 51/416 (12.3%) 35/207 (16.9%) 15/210 (7.1%) 50/416 (12%)
    Infections and infestations
    Bronchitis 12/416 (2.9%) 11/207 (5.3%) 4/210 (1.9%) 15/416 (3.6%)
    Nasopharyngitis 21/416 (5%) 17/207 (8.2%) 17/210 (8.1%) 25/416 (6%)
    Upper respiratory tract infection 42/416 (10.1%) 9/207 (4.3%) 14/210 (6.7%) 34/416 (8.2%)
    Urinary tract infection 19/416 (4.6%) 13/207 (6.3%) 11/210 (5.2%) 11/416 (2.6%)
    Investigations
    Alanine aminotransferase increased 23/416 (5.5%) 6/207 (2.9%) 3/210 (1.4%) 11/416 (2.6%)
    Nervous system disorders
    Headache 23/416 (5.5%) 8/207 (3.9%) 8/210 (3.8%) 25/416 (6%)
    Skin and subcutaneous tissue disorders
    Alopecia 17/416 (4.1%) 15/207 (7.2%) 4/210 (1.9%) 20/416 (4.8%)
    Vascular disorders
    Hypertension 21/416 (5%) 10/207 (4.8%) 15/210 (7.1%) 14/416 (3.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    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
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02886728
    Other Study ID Numbers:
    • GS-US-417-0303
    • 2016-000570-37
    First Posted:
    Sep 1, 2016
    Last Update Posted:
    Jun 1, 2021
    Last Verified:
    May 1, 2021