A Phase 3 interventional study of Filgotinib and Placebo to match filgotinib in Rheumatoid Arthritis, sponsored by Gilead Sciences. Completed at 187 sites in 31 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment
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).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 1,252 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Drug: Filgotinib · Drug: Placebo to match filgotinib · Drug: MTX
Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg
Drug: Filgotinib · Drug: Placebo to match filgotinib · Drug: MTX
Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX
Drug: Filgotinib · Drug: Placebo to match filgotinib · Drug: Placebo to match MTX
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Drug: Placebo to match filgotinib · Drug: MTX
Tablet(s) administered orally once daily
Also known as: GS-6034, GLPG0634
Tablet(s) administered orally once daily
Capsule(s) administered orally once weekly
Capsule(s) administered orally once weekly
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at 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.
Time frame: Week 24
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 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).
Time frame: Baseline; Week 24
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at 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.
Time frame: Week 24
Change From Baseline in the Modified Total Sharp Score (mTSS) at 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).
Time frame: Baseline; Week 24
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at 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.
Time frame: Baseline; Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at 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).
Time frame: Baseline; Week 24
Change From Baseline in the mTSS at 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).
Time frame: Baseline; Week 52
Percentage of Participants Who Achieved ACR20 Response at 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.
Time frame: Weeks 2, 4, 12, 36, and 52
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at 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.
Time frame: Weeks 2, 4, 12, 24, 36, and 52
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at 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.
Time frame: Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: HAQ-DI at 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).
Time frame: Baseline; Weeks 2, 4, 12, 36, and 52
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at 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.
Time frame: Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in DAS28 (CRP) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at 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.
Time frame: Weeks 4, 12, 24, and 52
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at 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.
Time frame: Weeks 2, 4, 12, 36, and 52
ACR N Percent Improvement (ACR-N) Response at 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.
Time frame: Weeks 2, 4, 12, 24, 36, and 52
Number of Participants With European League Against Rheumatism (EULAR) Response at 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.
Time frame: Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Clinical Disease Activity Index (CDAI) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Simplified Disease Activity Index (SDAI) at 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.
Time frame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
Percentage of Participants With no Radiographic Progression From Baseline at 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).
Time frame: Baseline; Weeks 24, and 52
SF-36 PCS Score at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in SF-36 PCS Score at 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.
Time frame: Baseline; Weeks 4, 12, 36, and 52
SF-36 Mental Component Summary (MCS) Score at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in SF-36 MCS Score at 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.
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
FACIT-Fatigue Score at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in FACIT-Fatigue Score at 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).
Time frame: Baseline; Weeks 4, 12, 36, and 52
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
EQ-5D Current Health VAS at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in EQ-5D Current Health VAS at 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).
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at 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.
Time frame: Weeks 4, 12, 24, 36, and 52
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at 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.
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at 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.
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at 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.
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at 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.
Time frame: Baseline; Weeks 4, 12, 24, 36, and 52
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.
| Milestone | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Started | 417 | 207 | 210 | 418 |
| Completed | 345 | 175 | 174 | 331 |
| Not completed | 72 | 32 | 36 | 87 |
| Withdrew: Withdrew consent | 31 | 13 | 11 | 47 |
| Withdrew: Lost to follow-up | 12 | 6 | 13 | 12 |
| Withdrew: Adverse event | 13 | 5 | 5 | 11 |
| Withdrew: Investigator's discretion | 11 | 7 | 5 | 11 |
| Withdrew: Death | 3 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 4 |
| Withdrew: Non-compliance with study drug | 1 | 0 | 1 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 1 | 0 |
| Withdrew: Randomized but not dosed | 1 | 0 | 0 | 2 |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | 81.0 (77.1 to 84.9) | 80.2 (74.5 to 85.9) | 78.1 (72.3 to 83.9) | 71.4 (66.9 to 75.9) |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 | 54.1 (49.2 to 59.0) | 42.5 (35.5 to 49.5) | 42.4 (35.5 to 49.3) | 29.1 (24.6 to 33.6) |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 | 42.1 (37.2 to 46.9) | 37.2 (30.4 to 44.0) | 39.5 (32.7 to 46.4) | 16.6 (12.9 to 20.3) |
| Week 4 | 62.3 (57.5 to 67.0) | 55.6 (48.5 to 62.6) | 52.4 (45.4 to 59.4) | 33.4 (28.8 to 38.1) |
| Week 12 | 76.7 (72.5 to 80.9) | 72.0 (65.6 to 78.3) | 71.4 (65.1 to 77.8) | 59.4 (54.5 to 64.2) |
| Week 36 | 75.5 (71.2 to 79.7) | 73.4 (67.2 to 79.7) | 76.2 (70.2 to 82.2) | 68.3 (63.7 to 72.9) |
| Week 52 | 75.0 (70.7 to 79.3) | 73.4 (67.2 to 79.7) | 74.8 (68.6 to 80.9) | 61.8 (57.0 to 66.6) |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 | 13.0 (9.6 to 16.3) | 9.2 (5.0 to 13.4) | 16.2 (11.0 to 21.4) | 2.9 (1.2 to 4.6) |
| Week 4 | 29.3 (24.8 to 33.8) | 20.8 (15.0 to 26.5) | 25.7 (19.6 to 31.9) | 9.4 (6.5 to 12.3) |
| Week 12 | 53.1 (48.2 to 58.0) | 44.4 (37.4 to 51.5) | 45.7 (38.7 to 52.7) | 28.4 (23.9 to 32.8) |
| Week 24 | 61.5 (56.7 to 66.3) | 57.0 (50.0 to 64.0) | 58.1 (51.2 to 65.0) | 45.7 (40.8 to 50.6) |
| Week 36 | 60.6 (55.8 to 65.4) | 55.6 (48.5 to 62.6) | 58.6 (51.7 to 65.5) | 48.6 (43.6 to 53.5) |
| Week 52 | 62.3 (57.5 to 67.0) | 59.4 (52.5 to 66.4) | 61.4 (54.6 to 68.3) | 48.3 (43.4 to 53.2) |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 | 3.1 (1.3 to 4.9) | 1.9 (0.0 to 4.0) | 4.3 (1.3 to 7.3) | 0.7 (0.0 to 1.7) |
| Week 4 | 13.0 (9.6 to 16.3) | 6.3 (2.7 to 9.8) | 11.4 (6.9 to 16.0) | 3.8 (1.9 to 5.8) |
| Week 12 | 32.9 (28.3 to 37.6) | 27.1 (20.8 to 33.3) | 29.0 (22.7 to 35.4) | 13.2 (9.8 to 16.6) |
| Week 24 | 43.8 (38.9 to 48.6) | 40.1 (33.2 to 47.0) | 40.0 (33.1 to 46.9) | 26.0 (21.6 to 30.3) |
| Week 36 | 45.9 (41.0 to 50.8) | 37.2 (30.4 to 44.0) | 39.5 (32.7 to 46.4) | 32.2 (27.6 to 36.8) |
| Week 52 | 47.8 (42.9 to 52.8) | 40.1 (33.2 to 47.0) | 45.2 (38.3 to 52.2) | 29.8 (25.3 to 34.3) |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| tender joint count | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| swollen joint count | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
| mg/L | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 | 61.9 (57.1 to 66.8) | 58.5 (51.4 to 65.6) | 53.9 (46.8 to 61.0) | 42.2 (37.3 to 47.1) |
| Week 4 | 72.4 (67.9 to 76.9) | 61.0 (54.0 to 68.0) | 68.6 (62.0 to 75.2) | 53.9 (49.0 to 58.8) |
| Week 12 | 80.3 (76.3 to 84.4) | 74.5 (68.2 to 80.8) | 74.0 (67.8 to 80.3) | 69.8 (65.2 to 74.3) |
| Week 24 | 76.6 (72.4 to 80.9) | 78.5 (72.6 to 84.4) | 77.0 (70.9 to 83.0) | 73.9 (69.5 to 78.3) |
| Week 36 | 73.4 (68.9 to 77.8) | 76.5 (70.4 to 82.6) | 73.5 (67.2 to 79.8) | 67.1 (62.4 to 71.7) |
| Week 52 | 70.9 (66.3 to 75.5) | 71.5 (65.0 to 78.0) | 70.6 (64.1 to 77.1) | 61.0 (56.1 to 65.8) |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 4 | 30.8 (26.2 to 35.3) | 23.7 (17.6 to 29.7) | 31.9 (25.4 to 38.4) | 12.0 (8.8 to 15.3) |
| Week 12 | 55.8 (50.9 to 60.7) | 50.2 (43.2 to 57.3) | 48.1 (41.1 to 55.1) | 28.6 (24.1 to 33.1) |
| Week 24 | 68.8 (64.2 to 73.3) | 62.8 (56.0 to 69.6) | 60.0 (53.1 to 66.9) | 46.2 (41.2 to 51.1) |
| Week 52 | 69.0 (64.4 to 73.6) | 59.9 (53.0 to 66.8) | 65.7 (59.1 to 72.4) | 47.6 (42.7 to 52.5) |
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.
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 | 7.2 (4.6 to 9.8) | 4.3 (1.3 to 7.4) | 10.0 (5.7 to 14.3) | 1.0 (0.0 to 2.0) |
| Week 4 | 16.6 (12.9 to 20.3) | 15.0 (9.9 to 20.1) | 19.5 (13.9 to 25.1) | 4.8 (2.6 to 7.0) |
| Week 12 | 39.7 (34.8 to 44.5) | 31.9 (25.3 to 38.5) | 29.5 (23.1 to 35.9) | 17.1 (13.3 to 20.8) |
| Week 36 | 52.6 (47.7 to 57.6) | 42.0 (35.1 to 49.0) | 43.3 (36.4 to 50.3) | 34.4 (29.7 to 39.1) |
| Week 52 | 53.4 (48.5 to 58.3) | 43.0 (36.0 to 50.0) | 46.2 (39.2 to 53.2) | 31.5 (26.9 to 36.1) |
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.
| percent improvement | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| Participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 2 — Good Response | 66 | 21 | 35 | 20 |
| Week 2 — Moderate Response | 199 | 92 | 88 | 118 |
| Week 2 — No Response | 134 | 86 | 77 | 258 |
| Week 4 — Good Response | 120 | 45 | 63 | 45 |
| Week 4 — Moderate Response | 206 | 104 | 97 | 161 |
| Week 4 — No Response | 77 | 50 | 42 | 195 |
| Week 12 — Good Response | 230 | 100 | 98 | 116 |
| Week 12 — Moderate Response | 130 | 79 | 77 | 190 |
| Week 12 — No Response | 26 | 16 | 14 | 74 |
| Week 24 — Good Response | 283 | 127 | 126 | 186 |
| Week 24 — Moderate Response | 82 | 55 | 52 | 153 |
| Week 24 — No Response | 9 | 8 | 5 | 29 |
| Week 36 — Good Response | 276 | 118 | 124 | 208 |
| Week 36 — Moderate Response | 64 | 54 | 51 | 106 |
| Week 36 — No Response | 7 | 5 | 2 | 7 |
| Week 52 — Good Response | 286 | 123 | 136 | 194 |
| Week 52 — Moderate Response | 43 | 43 | 30 | 102 |
| Week 52 — No Response | 3 | 4 | 3 | 11 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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).
| percentage of participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Week 24: Change in mTSS ≤ 0.5 | 89.6 (86.3 to 92.9) | 87.0 (81.8 to 92.1) | 89.6 (84.8 to 94.4) | 82.0 (77.9 to 86.2) |
| Week 24: Change in mTSS ≤ 0 | 80.6 (76.3 to 84.8) | 76.6 (70.2 to 83.0) | 82.7 (76.7 to 88.6) | 72.5 (67.7 to 77.3) |
| Week 24: Change in mTSS ≤ SDC (1.53) | 95.2 (92.8 to 97.6) | 93.5 (89.6 to 97.3) | 96.0 (92.7 to 99.2) | 91.6 (88.5 to 94.6) |
| Week 52: Change in mTSS ≤ 0.5 | 88.1 (84.6 to 91.7) | 85.8 (80.4 to 91.2) | 84.3 (78.5 to 90.2) | 77.9 (73.2 to 82.5) |
| Week 52: Change in mTSS ≤ 0 | 80.6 (76.3 to 84.9) | 76.1 (69.6 to 82.7) | 77.1 (70.4 to 83.8) | 70.6 (65.5 to 75.7) |
| Week 52: Change in mTSS ≤ SDC (1.77) | 94.2 (91.6 to 96.8) | 94.9 (91.3 to 98.4) | 89.2 (84.1 to 94.2) | 86.7 (82.8 to 90.5) |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| Participants | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| Mobility: Week 4 — No Problems | 161 | 66 | 81 | 104 |
| Mobility: Week 4 — Slight Problems | 149 | 68 | 56 | 135 |
| Mobility: Week 4 — Moderate Problems | 82 | 50 | 38 | 116 |
| Mobility: Week 4 — Severe Problems | 13 | 17 | 20 | 54 |
| Mobility: Week 4 — Extreme Problems | 1 | 1 | 6 | 1 |
| Mobility: Week 12 — No Problems | 198 | 87 | 86 | 138 |
| Mobility: Week 12 — Slight Problems | 135 | 56 | 60 | 135 |
| Mobility: Week 12 — Moderate Problems | 41 | 36 | 27 | 91 |
| Mobility: Week 12 — Severe Problems | 12 | 17 | 14 | 20 |
| Mobility: Week 12 — Extreme Problems | 4 | 0 | 5 | 4 |
| Mobility: Week 24 — No Problems | 208 | 92 | 95 | 152 |
| Mobility: Week 24 — Slight Problems | 116 | 55 | 50 | 135 |
| Mobility: Week 24 — Moderate Problems | 46 | 36 | 24 | 63 |
| Mobility: Week 24 — Severe Problems | 5 | 9 | 13 | 16 |
| Mobility: Week 24 — Extreme Problems | 2 | 0 | 2 | 4 |
| Mobility: Week 36 — No Problems | 216 | 93 | 98 | 152 |
| Mobility: Week 36 — Slight Problems | 96 | 60 | 46 | 135 |
| Mobility: Week 36 — Moderate Problems | 48 | 30 | 27 | 51 |
| Mobility: Week 36 — Severe Problems | 5 | 5 | 8 | 16 |
| Mobility: Week 36 — Extreme Problems | 0 | 0 | 1 | 2 |
| Mobility: Week 52 — No Problems | 217 | 91 | 93 | 156 |
| Mobility: Week 52 — Slight Problems | 92 | 50 | 47 | 108 |
| Mobility: Week 52 — Moderate Problems | 28 | 29 | 21 | 54 |
| Mobility: Week 52 — Severe Problems | 9 | 6 | 10 | 15 |
| Mobility: Week 52 — Extreme Problems | 1 | 0 | 3 | 1 |
| Self-Care: Week 4 — No Problems | 214 | 99 | 102 | 143 |
| Self-Care: Week 4 — Slight Problems | 142 | 63 | 50 | 141 |
| Self-Care: Week 4 — Moderate Problems | 42 | 28 | 38 | 96 |
| Self-Care: Week 4 — Severe Problems | 7 | 9 | 10 | 29 |
| Self-Care: Week 4 — Extreme Problems | 1 | 3 | 1 | 1 |
| Self-Care: Week 12 — No Problems | 277 | 113 | 111 | 190 |
| Self-Care: Week 12 — Slight Problems | 85 | 55 | 55 | 129 |
| Self-Care: Week 12 — Moderate Problems | 19 | 22 | 21 | 54 |
| Self-Care: Week 12 — Severe Problems | 6 | 5 | 4 | 13 |
| Self-Care: Week 12 — Extreme Problems | 3 | 1 | 1 | 2 |
| Self-Care: Week 24 — No Problems | 283 | 128 | 112 | 222 |
| Self-Care: Week 24 — Slight Problems | 73 | 42 | 52 | 95 |
| Self-Care: Week 24 — Moderate Problems | 16 | 20 | 17 | 46 |
| Self-Care: Week 24 — Severe Problems | 1 | 2 | 3 | 5 |
| Self-Care: Week 24 — Extreme Problems | 4 | 0 | 0 | 2 |
| Self-Care: Week 36 — No Problems | 271 | 122 | 121 | 224 |
| Self-Care: Week 36 — Slight Problems | 70 | 44 | 41 | 93 |
| Self-Care: Week 36 — Moderate Problems | 20 | 21 | 16 | 31 |
| Self-Care: Week 36 — Severe Problems | 3 | 1 | 1 | 5 |
| Self-Care: Week 36 — Extreme Problems | 1 | 0 | 1 | 3 |
| Self-Care: Week 52 — No Problems | 268 | 117 | 117 | 208 |
| Self-Care: Week 52 — Slight Problems | 60 | 36 | 36 | 84 |
| Self-Care: Week 52 — Moderate Problems | 13 | 21 | 16 | 35 |
| Self-Care: Week 52 — Severe Problems | 5 | 2 | 4 | 6 |
| Self-Care: Week 52 — Extreme Problems | 1 | 0 | 1 | 1 |
| Usual Activities: Week 4 — No Problems | 118 | 50 | 54 | 80 |
| Usual Activities: Week 4 — Slight Problems | 180 | 86 | 81 | 153 |
| Usual Activities: Week 4 — Moderate Problems | 90 | 47 | 49 | 122 |
| Usual Activities: Week 4 — Severe Problems | 16 | 19 | 14 | 49 |
| Usual Activities: Week 4 — Extreme Problems | 2 | 0 | 3 | 6 |
| Usual Activities: Week 12 — No Problems | 185 | 78 | 83 | 101 |
| Usual Activities: Week 12 — Slight Problems | 148 | 65 | 61 | 179 |
| Usual Activities: Week 12 — Moderate Problems | 44 | 42 | 35 | 85 |
| Usual Activities: Week 12 — Severe Problems | 11 | 9 | 11 | 19 |
| Usual Activities: Week 12 — Extreme Problems | 2 | 2 | 2 | 4 |
| Usual Activities: Week 24 — No Problems | 188 | 92 | 83 | 142 |
| Usual Activities: Week 24 — Slight Problems | 135 | 60 | 63 | 147 |
| Usual Activities: Week 24 — Moderate Problems | 43 | 31 | 30 | 64 |
| Usual Activities: Week 24 — Severe Problems | 8 | 9 | 8 | 13 |
| Usual Activities: Week 24 — Extreme Problems | 3 | 0 | 0 | 4 |
| Usual Activities: Week 36 — No Problems | 199 | 86 | 92 | 158 |
| Usual Activities: Week 36 — Slight Problems | 119 | 61 | 51 | 134 |
| Usual Activities: Week 36 — Moderate Problems | 42 | 37 | 31 | 50 |
| Usual Activities: Week 36 — Severe Problems | 5 | 4 | 3 | 12 |
| Usual Activities: Week 36 — Extreme Problems | 0 | 0 | 3 | 2 |
| Usual Activities: Week 52 — No Problems | 203 | 84 | 92 | 147 |
| Usual Activities: Week 52 — Slight Problems | 106 | 62 | 48 | 125 |
| Usual Activities: Week 52 — Moderate Problems | 31 | 22 | 27 | 50 |
| Usual Activities: Week 52 — Severe Problems | 7 | 7 | 5 | 10 |
| Usual Activities: Week 52 — Extreme Problems | 0 | 1 | 2 | 2 |
| Pain/Discomfort: Week 4 — No Problems | 45 | 23 | 21 | 18 |
| Pain/Discomfort: Week 4 — Slight Problems | 208 | 85 | 91 | 131 |
| Pain/Discomfort: Week 4 — Moderate Problems | 132 | 73 | 60 | 173 |
| Pain/Discomfort: Week 4 — Severe Problems | 21 | 19 | 26 | 78 |
| Pain/Discomfort: Week 4 — Extreme Problems | 0 | 2 | 3 | 10 |
| Pain/Discomfort: Week 12 — No Problems | 93 | 35 | 38 | 41 |
| Pain/Discomfort: Week 12 — Slight Problems | 202 | 96 | 81 | 167 |
| Pain/Discomfort: Week 12 — Moderate Problems | 83 | 47 | 53 | 143 |
| Pain/Discomfort: Week 12 — Severe Problems | 12 | 15 | 16 | 35 |
| Pain/Discomfort: Week 12 — Extreme Problems | 0 | 3 | 4 | 2 |
| Pain/Discomfort: Week 24 — No Problems | 110 | 46 | 40 | 44 |
| Pain/Discomfort: Week 24 — Slight Problems | 182 | 91 | 93 | 206 |
| Pain/Discomfort: Week 24 — Moderate Problems | 75 | 46 | 42 | 98 |
| Pain/Discomfort: Week 24 — Severe Problems | 9 | 9 | 7 | 22 |
| Pain/Discomfort: Week 24 — Extreme Problems | 1 | 0 | 2 | 0 |
| Pain/Discomfort: Week 36 — No Problems | 102 | 43 | 39 | 57 |
| Pain/Discomfort: Week 36 — Slight Problems | 188 | 90 | 87 | 195 |
| Pain/Discomfort: Week 36 — Moderate Problems | 68 | 41 | 44 | 85 |
| Pain/Discomfort: Week 36 — Severe Problems | 6 | 14 | 7 | 18 |
| Pain/Discomfort: Week 36 — Extreme Problems | 1 | 0 | 3 | 1 |
| Pain/Discomfort: Week 52 — No Problems | 108 | 46 | 49 | 63 |
| Pain/Discomfort: Week 52 — Slight Problems | 169 | 82 | 88 | 168 |
| Pain/Discomfort: Week 52 — Moderate Problems | 59 | 40 | 25 | 80 |
| Pain/Discomfort: Week 52 — Severe Problems | 11 | 8 | 9 | 22 |
| Pain/Discomfort: Week 52 — Extreme Problems | 0 | 0 | 3 | 1 |
| Anxiety/Depression: Week 4 — No Problems | 221 | 101 | 94 | 159 |
| Anxiety/Depression: Week 4 — Slight Problems | 126 | 58 | 64 | 148 |
| Anxiety/Depression: Week 4 — Moderate Problems | 53 | 33 | 35 | 73 |
| Anxiety/Depression: Week 4 — Severe Problems | 6 | 10 | 6 | 25 |
| Anxiety/Depression: Week 4 — Extreme Problems | 0 | 0 | 2 | 5 |
| Anxiety/Depression: Week 12 — No Problems | 233 | 104 | 106 | 198 |
| Anxiety/Depression: Week 12 — Slight Problems | 114 | 62 | 58 | 125 |
| Anxiety/Depression: Week 12 — Moderate Problems | 28 | 19 | 17 | 49 |
| Anxiety/Depression: Week 12 — Severe Problems | 14 | 9 | 10 | 15 |
| Anxiety/Depression: Week 12 — Extreme Problems | 1 | 2 | 1 | 1 |
| Anxiety/Depression: Week 24 — No Problems | 236 | 117 | 103 | 219 |
| Anxiety/Depression: Week 24 — Slight Problems | 97 | 47 | 64 | 93 |
| Anxiety/Depression: Week 24 — Moderate Problems | 32 | 25 | 11 | 42 |
| Anxiety/Depression: Week 24 — Severe Problems | 9 | 3 | 6 | 14 |
| Anxiety/Depression: Week 24 — Extreme Problems | 3 | 0 | 0 | 2 |
| Anxiety/Depression: Week 36 — No Problems | 233 | 119 | 103 | 194 |
| Anxiety/Depression: Week 36 — Slight Problems | 99 | 50 | 56 | 116 |
| Anxiety/Depression: Week 36 — Moderate Problems | 31 | 13 | 17 | 32 |
| Anxiety/Depression: Week 36 — Severe Problems | 2 | 5 | 3 | 12 |
| Anxiety/Depression: Week 36 — Extreme Problems | 0 | 1 | 1 | 2 |
| Anxiety/Depression: Week 52 — No Problems | 222 | 113 | 106 | 182 |
| Anxiety/Depression: Week 52 — Slight Problems | 94 | 40 | 43 | 100 |
| Anxiety/Depression: Week 52 — Moderate Problems | 26 | 18 | 20 | 45 |
| Anxiety/Depression: Week 52 — Severe Problems | 5 | 5 | 3 | 5 |
| Anxiety/Depression: Week 52 — Extreme Problems | 0 | 0 | 2 | 2 |
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.
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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).
| score on a scale | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of work time missed | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of impairment while working | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of overall work productivity | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of activity impairment | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of work time missed | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of impairment while working | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of overall work productivity | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
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.
| percentage of activity impairment | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| 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 |
Collected over First dose date up to last dose date (Maximum: 56 weeks) plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgotinib 200 mg + MTX | 3/416 (0.7%) | 26/416 (6.3%) | 179/416 (43%) |
| Filgotinib 100 mg + MTX | 1/207 (0.5%) | 13/207 (6.3%) | 88/207 (42.5%) |
| Filgotinib 200 mg Monotherapy | 0/210 (0%) | 17/210 (8.1%) | 78/210 (37.1%) |
| MTX Monotherapy | 0/416 (0%) | 28/416 (6.7%) | 164/416 (39.4%) |
| Event | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/416 | 2/207 | 1/210 | 1/416 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 0/416 | 2/207 | 1/210 | 0/416 |
| PneumoniaInfections and infestations | 4/416 | 1/207 | 0/210 | 1/416 |
| PancytopeniaBlood and lymphatic system disorders | 0/416 | 1/207 | 0/210 | 0/416 |
| Atrial fibrillationCardiac disorders | 0/416 | 1/207 | 0/210 | 1/416 |
| Appendiceal mucocoeleGastrointestinal disorders | 0/416 | 1/207 | 0/210 | 0/416 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/416 | 1/207 | 0/210 | 0/416 |
| Systemic inflammatory response syndromeGeneral disorders | 0/416 | 1/207 | 0/210 | 0/416 |
| Arthritis infectiveInfections and infestations | 0/416 | 1/207 | 0/210 | 0/416 |
| Pulmonary sepsisInfections and infestations | 0/416 | 1/207 | 0/210 | 0/416 |
| Event | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 51/416 | 35/207 | 15/210 | 50/416 |
| Upper respiratory tract infectionInfections and infestations | 42/416 | 9/207 | 14/210 | 34/416 |
| NasopharyngitisInfections and infestations | 21/416 | 17/207 | 17/210 | 25/416 |
| AlopeciaSkin and subcutaneous tissue disorders | 17/416 | 15/207 | 4/210 | 20/416 |
| HypertensionVascular disorders | 21/416 | 10/207 | 15/210 | 14/416 |
| Urinary tract infectionInfections and infestations | 19/416 | 13/207 | 11/210 | 11/416 |
| HeadacheNervous system disorders | 23/416 | 8/207 | 8/210 | 25/416 |
| DiarrhoeaGastrointestinal disorders | 17/416 | 12/207 | 6/210 | 21/416 |
| Alanine aminotransferase increasedInvestigations | 23/416 | 6/207 | 3/210 | 11/416 |
| BronchitisInfections and infestations | 12/416 | 11/207 | 4/210 | 15/416 |
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy | Total |
|---|---|---|---|---|---|
| Mean | 53 ± 13.8 | 54 ± 12.6 | 52 ± 13.9 | 53 ± 13.7 | 53 ± 13.6 |
| Sex: Female, Male(Participants) | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy | Total |
|---|---|---|---|---|---|
| Female | 325 | 158 | 166 | 312 | 961 |
| Male | 91 | 49 | 44 | 104 | 288 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy | Total |
|---|---|---|---|---|---|
| Race — American Indian or Alaska Native | 26 | 12 | 18 | 33 | 89 |
| Race — Asian: Japanese | 23 | 11 | 12 | 25 | 71 |
| Race — Asian: Chinese/Taiwanese/Hong Kong Chinese | 7 | 4 | 6 | 10 | 27 |
| Race — Asian: Vietnamese | 1 | 0 | 0 | 0 | 1 |
| Race — Asian: Korean | 6 | 8 | 2 | 8 | 24 |
| Race — Asian: Other | 53 | 28 | 27 | 42 | 150 |
| Race — Black or African American | 15 | 8 | 8 | 14 | 45 |
| Race — Native Hawaiian or Pacific Islander | 1 | 0 | 1 | 3 | 5 |
| Race — White | 278 | 132 | 135 | 278 | 823 |
| Race — Other | 6 | 4 | 0 | 3 | 13 |
| Race — Not Permitted | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy | Total |
|---|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 93 | 40 | 45 | 84 | 262 |
| Ethnicity — Not Hispanic or Latino | 322 | 167 | 165 | 332 | 986 |
| Ethnicity — Not Permitted | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Filgotinib 200 mg Monotherapy | MTX Monotherapy | Total |
|---|---|---|---|---|---|
| United States | 112 | 47 | 54 | 106 | 319 |
| Spain | 12 | 5 | 7 | 10 | 34 |
| Germany | 7 | 7 | 6 | 10 | 30 |
| South Korea | 6 | 8 | 2 | 8 | 24 |
| Canada | 5 | 5 | 4 | 6 | 20 |
| Belgium | 3 | 2 | 6 | 8 | 19 |
| South Africa | 8 | 5 | 1 | 5 | 19 |
| Australia | 7 | 2 | 2 | 7 | 18 |
| New Zealand | 9 | 3 | 0 | 4 | 16 |
| United Kingdom | 1 | 1 | 1 | 5 | 8 |
| Italy | 2 | 0 | 1 | 0 | 3 |
| Ireland | 1 | 0 | 0 | 1 | 2 |
| Israel | 0 | 0 | 2 | 0 | 2 |
| India | 41 | 21 | 22 | 31 | 115 |
| Poland | 35 | 21 | 15 | 37 | 108 |
| Ukraine | 21 | 10 | 13 | 25 | 69 |
| Bulgaria | 17 | 11 | 8 | 18 | 54 |
| Russia | 9 | 4 | 4 | 14 | 31 |
| Czechia | 5 | 3 | 3 | 9 | 20 |
| Hungary | 7 | 2 | 3 | 6 | 18 |
| Serbia | 6 | 2 | 4 | 4 | 16 |
| Romania | 4 | 1 | 2 | 3 | 10 |
| Slovakia | 4 | 0 | 2 | 2 | 8 |
| Mexico | 35 | 20 | 23 | 38 | 116 |
| Argentina | 16 | 5 | 4 | 15 | 40 |
| Chile | 7 | 3 | 1 | 3 | 14 |
| Taiwan | 7 | 2 | 5 | 9 | 23 |
| Thailand | 5 | 2 | 1 | 5 | 13 |
| Malaysia | 1 | 3 | 1 | 1 | 6 |
| Hong Kong | 0 | 1 | 1 | 1 | 3 |
| Japan | 23 | 11 | 12 | 25 | 71 |
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