Rheumatoid Arthritis
Conditions
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Interventions
DRUGFilgotinib
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
DRUGMTX
Capsule(s) administered orally once weekly
DRUGPlacebo to match MTX
Capsule(s) administered orally once weekly
Sponsors
Galapagos NV
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have a diagnosis of RA (2010 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria) and are ACR functional class I-III. * Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1. * Limited or no prior treatment with MTX Key
Exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor * Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine * Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs) NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | Week 24 | ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 | Week 24 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Baseline; Week 24 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet \[where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion\]). JSN is scored from 0 to 4 \[0 indicating no/normal JSN and 4 indicating complete loss of joint space\]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces). |
| Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline; Week 24 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Baseline; Week 24 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Change From Baseline in the mTSS at Week 52 | Baseline; Week 52 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet \[where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion\]). JSN is scored from 0 to 4 \[0 indicating no/normal JSN and 4 indicating complete loss of joint space\]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces). |
| Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Weeks 2, 4, 12, 36, and 52 | ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Weeks 2, 4, 12, 24, 36, and 52 | ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Weeks 2, 4, 12, 24, 36, and 52 | ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Baseline; Weeks 2, 4, 12, 36, and 52 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability). |
| Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | The participant assessed their pain severity using a VAS on a scale of 0 ( no pain) to 100 (severe pain). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | — |
| Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Weeks 2, 4, 12, 24, 36, and 52 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 \[0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled)\] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Weeks 4, 12, 24, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Weeks 2, 4, 12, 36, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Weeks 2, 4, 12, 24, 36, and 52 | ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement. |
| Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Weeks 2, 4, 12, 24, 36, and 52 | Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>0.6 and ≤1.2; DAS28(CRP) at visit \>3.2 and ≤5.1 and improvement from baseline \>0.6; DAS 28(CRP) at visit \>5.1 and improvement from baseline \>1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) \>5.1 at visit and improvement from baseline ≤1.2. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline; Weeks 2, 4, 12, 24, 36, and 52 | SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement. |
| Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Baseline; Weeks 24, and 52 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC). |
| SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Baseline; Weeks 4, 12, 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52. |
| Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Baseline; Weeks 4, 12, 36, and 52 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health). |
| Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity. |
| WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity. |
| WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline; Week 24 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 \[0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices\]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled)\] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). |
| Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline; Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity. |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, and South America. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.
Pre-assignment details
1855 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib 200 mg + MTX Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. | 416 |
| Filgotinib 100 mg + MTX Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. | 207 |
| Filgotinib 200 mg Monotherapy Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. | 210 |
| MTX Monotherapy Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks. | 416 |
| Total | 1,249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 5 | 5 | 11 |
| Overall Study | Death | 3 | 1 | 0 | 0 |
| Overall Study | Investigator's Discretion | 11 | 7 | 5 | 11 |
| Overall Study | Lost to Follow-up | 12 | 6 | 13 | 12 |
| Overall Study | Non-Compliance with Study Drug | 1 | 0 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 4 |
| Overall Study | Randomized but Not Dosed | 1 | 0 | 0 | 2 |
| Overall Study | Withdrew Consent | 31 | 13 | 11 | 47 |
Baseline characteristics
| Characteristic | Filgotinib 200 mg + MTX | Filgotinib 100 mg + MTX | Total | MTX Monotherapy | Filgotinib 200 mg Monotherapy |
|---|---|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 13.8 | 54 years STANDARD_DEVIATION 12.6 | 53 years STANDARD_DEVIATION 13.6 | 53 years STANDARD_DEVIATION 13.7 | 52 years STANDARD_DEVIATION 13.9 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 93 Participants | 40 Participants | 262 Participants | 84 Participants | 45 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 322 Participants | 167 Participants | 986 Participants | 332 Participants | 165 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 26 Participants | 12 Participants | 89 Participants | 33 Participants | 18 Participants |
| Race/Ethnicity, Customized Race Asian: Chinese/Taiwanese/Hong Kong Chinese | 7 Participants | 4 Participants | 27 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Asian: Japanese | 23 Participants | 11 Participants | 71 Participants | 25 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Asian: Korean | 6 Participants | 8 Participants | 24 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian: Other | 53 Participants | 28 Participants | 150 Participants | 42 Participants | 27 Participants |
| Race/Ethnicity, Customized Race Asian: Vietnamese | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 15 Participants | 8 Participants | 45 Participants | 14 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 4 Participants | 13 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 278 Participants | 132 Participants | 823 Participants | 278 Participants | 135 Participants |
| Region of Enrollment Argentina | 16 Participants | 5 Participants | 40 Participants | 15 Participants | 4 Participants |
| Region of Enrollment Australia | 7 Participants | 2 Participants | 18 Participants | 7 Participants | 2 Participants |
| Region of Enrollment Belgium | 3 Participants | 2 Participants | 19 Participants | 8 Participants | 6 Participants |
| Region of Enrollment Bulgaria | 17 Participants | 11 Participants | 54 Participants | 18 Participants | 8 Participants |
| Region of Enrollment Canada | 5 Participants | 5 Participants | 20 Participants | 6 Participants | 4 Participants |
| Region of Enrollment Chile | 7 Participants | 3 Participants | 14 Participants | 3 Participants | 1 Participants |
| Region of Enrollment Czechia | 5 Participants | 3 Participants | 20 Participants | 9 Participants | 3 Participants |
| Region of Enrollment Germany | 7 Participants | 7 Participants | 30 Participants | 10 Participants | 6 Participants |
| Region of Enrollment Hong Kong | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Hungary | 7 Participants | 2 Participants | 18 Participants | 6 Participants | 3 Participants |
| Region of Enrollment India | 41 Participants | 21 Participants | 115 Participants | 31 Participants | 22 Participants |
| Region of Enrollment Ireland | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Israel | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Italy | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Japan | 23 Participants | 11 Participants | 71 Participants | 25 Participants | 12 Participants |
| Region of Enrollment Malaysia | 1 Participants | 3 Participants | 6 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Mexico | 35 Participants | 20 Participants | 116 Participants | 38 Participants | 23 Participants |
| Region of Enrollment New Zealand | 9 Participants | 3 Participants | 16 Participants | 4 Participants | 0 Participants |
| Region of Enrollment Poland | 35 Participants | 21 Participants | 108 Participants | 37 Participants | 15 Participants |
| Region of Enrollment Romania | 4 Participants | 1 Participants | 10 Participants | 3 Participants | 2 Participants |
| Region of Enrollment Russia | 9 Participants | 4 Participants | 31 Participants | 14 Participants | 4 Participants |
| Region of Enrollment Serbia | 6 Participants | 2 Participants | 16 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Slovakia | 4 Participants | 0 Participants | 8 Participants | 2 Participants | 2 Participants |
| Region of Enrollment South Africa | 8 Participants | 5 Participants | 19 Participants | 5 Participants | 1 Participants |
| Region of Enrollment South Korea | 6 Participants | 8 Participants | 24 Participants | 8 Participants | 2 Participants |
| Region of Enrollment Spain | 12 Participants | 5 Participants | 34 Participants | 10 Participants | 7 Participants |
| Region of Enrollment Taiwan | 7 Participants | 2 Participants | 23 Participants | 9 Participants | 5 Participants |
| Region of Enrollment Thailand | 5 Participants | 2 Participants | 13 Participants | 5 Participants | 1 Participants |
| Region of Enrollment Ukraine | 21 Participants | 10 Participants | 69 Participants | 25 Participants | 13 Participants |
| Region of Enrollment United Kingdom | 1 Participants | 1 Participants | 8 Participants | 5 Participants | 1 Participants |
| Region of Enrollment United States | 112 Participants | 47 Participants | 319 Participants | 106 Participants | 54 Participants |
| Sex: Female, Male Female | 325 Participants | 158 Participants | 961 Participants | 312 Participants | 166 Participants |
| Sex: Female, Male Male | 91 Participants | 49 Participants | 288 Participants | 104 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 416 | 1 / 207 | 0 / 210 | 0 / 416 |
| other Total, other adverse events | 179 / 416 | 88 / 207 | 78 / 210 | 164 / 416 |
| serious Total, serious adverse events | 26 / 416 | 13 / 207 | 17 / 210 | 28 / 416 |
Outcome results
Primary
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
Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | 81.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | 80.2 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | 78.1 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 | 71.4 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [3.6, 15.6]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: 0.01795% CI: [1.5, 16.1]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: 0.05895% CI: [-0.7, 14.1]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 52.6 percent improvement | Standard Deviation 29.91 |
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 65.8 percent improvement | Standard Deviation 28.5 |
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 62.8 percent improvement | Standard Deviation 28.4 |
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 69.6 percent improvement | Standard Deviation 27.38 |
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 34.1 percent improvement | Standard Deviation 27.78 |
| Filgotinib 200 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 20.8 percent improvement | Standard Deviation 21.42 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 46.1 percent improvement | Standard Deviation 31.46 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 17.8 percent improvement | Standard Deviation 20.07 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 58.7 percent improvement | Standard Deviation 30.99 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 27.6 percent improvement | Standard Deviation 24.81 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 58.1 percent improvement | Standard Deviation 30.19 |
| Filgotinib 100 mg + MTX | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 63.6 percent improvement | Standard Deviation 29.19 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 62.1 percent improvement | Standard Deviation 28.12 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 67.4 percent improvement | Standard Deviation 26.6 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 20.9 percent improvement | Standard Deviation 23.19 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 29.4 percent improvement | Standard Deviation 27.86 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 48.6 percent improvement | Standard Deviation 30.5 |
| Filgotinib 200 mg Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 59.7 percent improvement | Standard Deviation 29.35 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 49.0 percent improvement | Standard Deviation 29.46 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 34.3 percent improvement | Standard Deviation 28.07 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 17.2 percent improvement | Standard Deviation 21.43 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 8.9 percent improvement | Standard Deviation 14.95 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 57.3 percent improvement | Standard Deviation 29.16 |
| MTX Monotherapy | ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 57.1 percent improvement | Standard Deviation 29.59 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline | 33.9 score on a scale | Standard Deviation 7.48 |
| Filgotinib 200 mg + MTX | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Change at Week 24 | 12.3 score on a scale | Standard Deviation 8.89 |
| Filgotinib 100 mg + MTX | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Change at Week 24 | 11.1 score on a scale | Standard Deviation 9 |
| Filgotinib 100 mg + MTX | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline | 33.7 score on a scale | Standard Deviation 8 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline | 33.6 score on a scale | Standard Deviation 7.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Change at Week 24 | 10.4 score on a scale | Standard Deviation 9.09 |
| MTX Monotherapy | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline | 33.3 score on a scale | Standard Deviation 7.28 |
| MTX Monotherapy | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Change at Week 24 | 9.7 score on a scale | Standard Deviation 8.62 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.8, 4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02195% CI: [0.2, 2.9]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2495% CI: [-0.5, 2.2]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 39.5 score on a scale | Standard Deviation 12.77 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -27.8 score on a scale | Standard Deviation 13.6 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -19.9 score on a scale | Standard Deviation 13.64 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -33.8 score on a scale | Standard Deviation 13 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -32.2 score on a scale | Standard Deviation 13.37 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -31.3 score on a scale | Standard Deviation 13.19 |
| Filgotinib 200 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -13.6 score on a scale | Standard Deviation 12.05 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -31.9 score on a scale | Standard Deviation 12.22 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 39.2 score on a scale | Standard Deviation 12.69 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -12.0 score on a scale | Standard Deviation 10.54 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -17.8 score on a scale | Standard Deviation 12.06 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -26.1 score on a scale | Standard Deviation 13 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -30.0 score on a scale | Standard Deviation 13.32 |
| Filgotinib 100 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -30.8 score on a scale | Standard Deviation 12.84 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -27.5 score on a scale | Standard Deviation 13.55 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 40.0 score on a scale | Standard Deviation 12.63 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -33.6 score on a scale | Standard Deviation 12.28 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -31.3 score on a scale | Standard Deviation 12.57 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -32.7 score on a scale | Standard Deviation 12.16 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -18.4 score on a scale | Standard Deviation 12.96 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -13.9 score on a scale | Standard Deviation 12.53 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -13.3 score on a scale | Standard Deviation 12.61 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -31.3 score on a scale | Standard Deviation 12.66 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -22.7 score on a scale | Standard Deviation 13.38 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 40.2 score on a scale | Standard Deviation 12.5 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -28.2 score on a scale | Standard Deviation 13.43 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -31.2 score on a scale | Standard Deviation 13.12 |
| MTX Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -8.5 score on a scale | Standard Deviation 11.33 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.3, -4.1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.4, -2.4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.7, -3.7]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.9, -5.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.3, -3.3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.8, -3.7]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.3, -4.4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.1, -2.7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.8, -3.4]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.3, -2.9]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.3, -1.3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.4, -1.4]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3.4, -1.1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3695% CI: [-2, 0.8]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00995% CI: [-3.3, -0.5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.5, -2.2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04295% CI: [-2.7, -0.1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3.7, -1]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 5.7 score on a scale | Standard Deviation 0.99 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -3.3 score on a scale | Standard Deviation 1.28 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -3.2 score on a scale | Standard Deviation 1.31 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -1.3 score on a scale | Standard Deviation 1.06 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -3.4 score on a scale | Standard Deviation 1.23 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -1.9 score on a scale | Standard Deviation 1.26 |
| Filgotinib 200 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -2.7 score on a scale | Standard Deviation 1.31 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -3.0 score on a scale | Standard Deviation 1.26 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -2.5 score on a scale | Standard Deviation 1.28 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -1.6 score on a scale | Standard Deviation 1.14 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -2.9 score on a scale | Standard Deviation 1.3 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -3.1 score on a scale | Standard Deviation 1.24 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -1.1 score on a scale | Standard Deviation 0.92 |
| Filgotinib 100 mg + MTX | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 5.7 score on a scale | Standard Deviation 1.04 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -2.6 score on a scale | Standard Deviation 1.26 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 5.8 score on a scale | Standard Deviation 0.94 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -1.4 score on a scale | Standard Deviation 1.12 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -1.8 score on a scale | Standard Deviation 1.2 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -3.0 score on a scale | Standard Deviation 1.16 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -3.2 score on a scale | Standard Deviation 1.12 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -3.3 score on a scale | Standard Deviation 1.11 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -1.0 score on a scale | Standard Deviation 1.04 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -2.8 score on a scale | Standard Deviation 1.29 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -2.9 score on a scale | Standard Deviation 1.22 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -0.6 score on a scale | Standard Deviation 0.87 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 5.7 score on a scale | Standard Deviation 1 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -2.5 score on a scale | Standard Deviation 1.29 |
| MTX Monotherapy | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -1.9 score on a scale | Standard Deviation 1.21 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.7, -0.4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.1, -0.8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.5]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1, -0.7]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1, -0.7]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.8, -0.4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.7, -0.3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.7, -0.3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.6, -0.3]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03395% CI: [-0.4, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.6, -0.2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.8, -0.5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.6, -0.2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.7, -0.3]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 23 score on a scale | Standard Deviation 29.7 |
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 16 score on a scale | Standard Deviation 25 |
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 26 score on a scale | Standard Deviation 31.1 |
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 24 score on a scale | Standard Deviation 28.1 |
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 19 score on a scale | Standard Deviation 29.8 |
| Filgotinib 200 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Baseline | 50 score on a scale | Standard Deviation 22 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Baseline | 50 score on a scale | Standard Deviation 24.6 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 10 score on a scale | Standard Deviation 24.6 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 22 score on a scale | Standard Deviation 31.5 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 21 score on a scale | Standard Deviation 28.6 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 21 score on a scale | Standard Deviation 27.7 |
| Filgotinib 100 mg + MTX | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 17 score on a scale | Standard Deviation 28 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Baseline | 51 score on a scale | Standard Deviation 22.5 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 18 score on a scale | Standard Deviation 28.8 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 20 score on a scale | Standard Deviation 30.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 11 score on a scale | Standard Deviation 22.4 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 15 score on a scale | Standard Deviation 26.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 17 score on a scale | Standard Deviation 29 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 19 score on a scale | Standard Deviation 29.8 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 19 score on a scale | Standard Deviation 28.8 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 14 score on a scale | Standard Deviation 27.7 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Baseline | 50 score on a scale | Standard Deviation 22.1 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 7 score on a scale | Standard Deviation 25 |
| MTX Monotherapy | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 22 score on a scale | Standard Deviation 30.6 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [6, 12]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [1, 8]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [3, 9]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2, 8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.08995% CI: [0, 7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1895% CI: [-1, 6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [1, 7]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04995% CI: [0, 7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.8495% CI: [-4, 3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2, 9]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07895% CI: [0, 7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3995% CI: [-2, 6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00495% CI: [2, 8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.4595% CI: [-3, 6]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.8595% CI: [-4, 5]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 7.0 score on a scale | Standard Deviation 9.46 |
| Filgotinib 200 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Baseline | 28.3 score on a scale | Standard Deviation 10.93 |
| Filgotinib 200 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 9.8 score on a scale | Standard Deviation 11.2 |
| Filgotinib 200 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.7 score on a scale | Standard Deviation 11.52 |
| Filgotinib 200 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.3 score on a scale | Standard Deviation 11.21 |
| Filgotinib 100 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 9.2 score on a scale | Standard Deviation 11.21 |
| Filgotinib 100 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Baseline | 27.3 score on a scale | Standard Deviation 11.92 |
| Filgotinib 100 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 6.7 score on a scale | Standard Deviation 9.64 |
| Filgotinib 100 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.9 score on a scale | Standard Deviation 11.53 |
| Filgotinib 100 mg + MTX | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.9 score on a scale | Standard Deviation 12.29 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 9.4 score on a scale | Standard Deviation 10.57 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Baseline | 27.3 score on a scale | Standard Deviation 10.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.5 score on a scale | Standard Deviation 11.17 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 10.9 score on a scale | Standard Deviation 10.81 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 6.8 score on a scale | Standard Deviation 9.94 |
| MTX Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.1 score on a scale | Standard Deviation 10.91 |
| MTX Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 8.1 score on a scale | Standard Deviation 10.09 |
| MTX Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Baseline | 27.1 score on a scale | Standard Deviation 10.72 |
| MTX Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.3 score on a scale | Standard Deviation 11.49 |
| MTX Monotherapy | Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 4.3 score on a scale | Standard Deviation 9.24 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.1, 4.4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.1, 3.9]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.3, 4.1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1, 3.5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1395% CI: [-0.4, 2.7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03295% CI: [0.1, 3.2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02895% CI: [0.2, 2.8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1595% CI: [-0.4, 2.7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.4195% CI: [-0.9, 2.3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.01795% CI: [0.3, 3.1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2795% CI: [-0.7, 2.6]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1595% CI: [-0.5, 2.9]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Change at Week 24 | 10.6 score on a scale | Standard Deviation 11.49 |
| Filgotinib 200 mg + MTX | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Baseline | 28.3 score on a scale | Standard Deviation 10.93 |
| Filgotinib 100 mg + MTX | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Baseline | 27.3 score on a scale | Standard Deviation 11.92 |
| Filgotinib 100 mg + MTX | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Change at Week 24 | 11.4 score on a scale | Standard Deviation 11.26 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Change at Week 24 | 10.2 score on a scale | Standard Deviation 11.37 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Baseline | 27.3 score on a scale | Standard Deviation 10.9 |
| MTX Monotherapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Change at Week 24 | 10.1 score on a scale | Standard Deviation 11.19 |
| MTX Monotherapy | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 | Baseline | 27.1 score on a scale | Standard Deviation 10.72 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.05695% CI: [0, 2.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.195% CI: [-0.3, 3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.6795% CI: [-1.3, 2]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 36 | -0.96 score on a scale | Standard Deviation 0.725 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Baseline | 1.52 score on a scale | Standard Deviation 0.622 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 52 | -1.00 score on a scale | Standard Deviation 0.728 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 4 | -0.57 score on a scale | Standard Deviation 0.587 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 2 | -0.37 score on a scale | Standard Deviation 0.495 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 12 | -0.85 score on a scale | Standard Deviation 0.698 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 36 | -0.93 score on a scale | Standard Deviation 0.7 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 12 | -0.77 score on a scale | Standard Deviation 0.67 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 52 | -0.97 score on a scale | Standard Deviation 0.719 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 2 | -0.36 score on a scale | Standard Deviation 0.49 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Baseline | 1.56 score on a scale | Standard Deviation 0.654 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 4 | -0.45 score on a scale | Standard Deviation 0.547 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 4 | -0.51 score on a scale | Standard Deviation 0.526 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Baseline | 1.56 score on a scale | Standard Deviation 0.655 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 2 | -0.32 score on a scale | Standard Deviation 0.442 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 12 | -0.76 score on a scale | Standard Deviation 0.625 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 36 | -0.91 score on a scale | Standard Deviation 0.673 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 52 | -0.95 score on a scale | Standard Deviation 0.688 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 52 | -0.88 score on a scale | Standard Deviation 0.685 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 36 | -0.89 score on a scale | Standard Deviation 0.675 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 2 | -0.18 score on a scale | Standard Deviation 0.426 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Baseline | 1.60 score on a scale | Standard Deviation 0.625 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 12 | -0.61 score on a scale | Standard Deviation 0.582 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 | Change at Week 4 | -0.32 score on a scale | Standard Deviation 0.511 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.29, -0.17]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.28, -0.13]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.24, -0.09]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.35, -0.22]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.23, -0.06]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.29, -0.12]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.35, -0.2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.28, -0.09]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.26, -0.07]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [-0.22, -0.05]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2395% CI: [-0.17, 0.04]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2495% CI: [-0.16, 0.04]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.25, -0.08]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07795% CI: [-0.2, 0.01]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03995% CI: [-0.22, -0.01]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -12.89 mg/L | Standard Deviation 23.401 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -13.77 mg/L | Standard Deviation 23.585 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -13.79 mg/L | Standard Deviation 23.569 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -13.84 mg/L | Standard Deviation 25.18 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -13.43 mg/L | Standard Deviation 27.086 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 18.04 mg/L | Standard Deviation 25.289 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -12.99 mg/L | Standard Deviation 26.823 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -10.85 mg/L | Standard Deviation 24.458 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -11.61 mg/L | Standard Deviation 23.857 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -9.40 mg/L | Standard Deviation 18.93 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -12.64 mg/L | Standard Deviation 22.736 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -11.53 mg/L | Standard Deviation 20.596 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -11.02 mg/L | Standard Deviation 20.272 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 17.72 mg/L | Standard Deviation 27.419 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -12.29 mg/L | Standard Deviation 23.09 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 17.32 mg/L | Standard Deviation 23.228 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -11.52 mg/L | Standard Deviation 26.863 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -12.04 mg/L | Standard Deviation 24.69 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -10.97 mg/L | Standard Deviation 20.249 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -12.66 mg/L | Standard Deviation 24.525 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -10.95 mg/L | Standard Deviation 23.319 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -7.96 mg/L | Standard Deviation 23.835 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 16.86 mg/L | Standard Deviation 24.353 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -0.99 mg/L | Standard Deviation 14.392 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -3.18 mg/L | Standard Deviation 18.534 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -7.23 mg/L | Standard Deviation 21.823 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -8.74 mg/L | Standard Deviation 23.579 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -7.47 mg/L | Standard Deviation 23.511 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12.71, -8.85]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.13, -6.39]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7.29]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.65, -8.19]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10.47, -6.21]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.45, -5.21]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.56, -4.39]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.14, -2.27]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.29, -2.39]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.24, -3.31]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00795% CI: [-5.68, -0.89]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.02, -2.2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.35, -1.53]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00495% CI: [-5.72, -1.09]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07295% CI: [-4.44, 0.19]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.34, -3.24]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [-4.88, -1.13]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.65, -1.89]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 66.0 score on a scale | Standard Deviation 17 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -53.0 score on a scale | Standard Deviation 20.5 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -56.0 score on a scale | Standard Deviation 20 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -24.0 score on a scale | Standard Deviation 20.3 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -34.0 score on a scale | Standard Deviation 22.3 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -47.0 score on a scale | Standard Deviation 21.4 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -51.0 score on a scale | Standard Deviation 21.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -21.0 score on a scale | Standard Deviation 19.4 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -32.0 score on a scale | Standard Deviation 22.5 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -51.0 score on a scale | Standard Deviation 22.3 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -51.0 score on a scale | Standard Deviation 22.2 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -43.0 score on a scale | Standard Deviation 22.5 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 68.0 score on a scale | Standard Deviation 16.3 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -54.0 score on a scale | Standard Deviation 20.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -42.0 score on a scale | Standard Deviation 20.8 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -23.0 score on a scale | Standard Deviation 19.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -52.0 score on a scale | Standard Deviation 18.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -49.0 score on a scale | Standard Deviation 19.5 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 66.0 score on a scale | Standard Deviation 14.4 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -30.0 score on a scale | Standard Deviation 21.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -55.0 score on a scale | Standard Deviation 17.5 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -51.0 score on a scale | Standard Deviation 20.2 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -15.0 score on a scale | Standard Deviation 18.9 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -23.0 score on a scale | Standard Deviation 20.7 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -38.0 score on a scale | Standard Deviation 21.9 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -46.0 score on a scale | Standard Deviation 21.4 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -51.0 score on a scale | Standard Deviation 20.6 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 67.0 score on a scale | Standard Deviation 16.8 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9, -2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -8]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9, -2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00195% CI: [-8, -2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8, -3]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00795% CI: [-7, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04695% CI: [-6, 0]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [-6, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.4495% CI: [-4, 2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2195% CI: [-5, 1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -3]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02995% CI: [-6, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.0195% CI: [-6, -1]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 65.0 score on a scale | Standard Deviation 21 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -43.0 score on a scale | Standard Deviation 27.2 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -42.0 score on a scale | Standard Deviation 26.8 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -17.0 score on a scale | Standard Deviation 20.8 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -45.0 score on a scale | Standard Deviation 27 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -26.0 score on a scale | Standard Deviation 24.7 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -37.0 score on a scale | Standard Deviation 26.7 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -39.0 score on a scale | Standard Deviation 27.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -30.0 score on a scale | Standard Deviation 26.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -20.0 score on a scale | Standard Deviation 22.5 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -36.0 score on a scale | Standard Deviation 27.4 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -41.0 score on a scale | Standard Deviation 28.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -13.0 score on a scale | Standard Deviation 18.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 66.0 score on a scale | Standard Deviation 21.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -32.0 score on a scale | Standard Deviation 27.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 68.0 score on a scale | Standard Deviation 19.2 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -14.0 score on a scale | Standard Deviation 20.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -22.0 score on a scale | Standard Deviation 24.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -38.0 score on a scale | Standard Deviation 26.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -39.0 score on a scale | Standard Deviation 24.3 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -43.0 score on a scale | Standard Deviation 25.4 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -14.0 score on a scale | Standard Deviation 22.2 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -38.0 score on a scale | Standard Deviation 28.3 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -38.0 score on a scale | Standard Deviation 28 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -7.0 score on a scale | Standard Deviation 18.9 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 66.0 score on a scale | Standard Deviation 21 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -34.0 score on a scale | Standard Deviation 27.4 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -25.0 score on a scale | Standard Deviation 25.9 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -10]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00195% CI: [-10, -2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -4]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -9]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00995% CI: [-9, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [-10, -2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1195% CI: [-7, 1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.06695% CI: [-8, 0]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.495% CI: [-6, 2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2495% CI: [-6, 2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1795% CI: [-7, 1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00895% CI: [-10, -1]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 64.0 score on a scale | Standard Deviation 22 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -43.0 score on a scale | Standard Deviation 28 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -41.0 score on a scale | Standard Deviation 28 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -18.0 score on a scale | Standard Deviation 22.2 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -45.0 score on a scale | Standard Deviation 27.9 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -26.0 score on a scale | Standard Deviation 24.8 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -37.0 score on a scale | Standard Deviation 27.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -40.0 score on a scale | Standard Deviation 28.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -31.0 score on a scale | Standard Deviation 26.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -22.0 score on a scale | Standard Deviation 23.7 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -37.0 score on a scale | Standard Deviation 27.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -43.0 score on a scale | Standard Deviation 27.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -15.0 score on a scale | Standard Deviation 20.3 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 67.0 score on a scale | Standard Deviation 22.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -32.0 score on a scale | Standard Deviation 28.3 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 67.0 score on a scale | Standard Deviation 18.4 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -17.0 score on a scale | Standard Deviation 21.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -24.0 score on a scale | Standard Deviation 25.3 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -39.0 score on a scale | Standard Deviation 26.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -38.0 score on a scale | Standard Deviation 25.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -44.0 score on a scale | Standard Deviation 24.2 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -14.0 score on a scale | Standard Deviation 23.6 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -37.0 score on a scale | Standard Deviation 30.5 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -38.0 score on a scale | Standard Deviation 29.3 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -7.0 score on a scale | Standard Deviation 20.1 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 66.0 score on a scale | Standard Deviation 21.4 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -34.0 score on a scale | Standard Deviation 27.6 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -26.0 score on a scale | Standard Deviation 27 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -9]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -5]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-16, -10]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -4]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.01995% CI: [-9, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00795% CI: [-10, -2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1395% CI: [-7, 1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04795% CI: [-8, 0]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3495% CI: [-6, 2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.4695% CI: [-6, 3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.0395% CI: [-9, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -3]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -14.0 swollen joint count | Standard Deviation 9.1 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -14.0 swollen joint count | Standard Deviation 8.9 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -15.0 swollen joint count | Standard Deviation 9.2 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -7.0 swollen joint count | Standard Deviation 8 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 16.0 swollen joint count | Standard Deviation 9.8 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -9.0 swollen joint count | Standard Deviation 8.7 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -13.0 swollen joint count | Standard Deviation 8.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -14.0 swollen joint count | Standard Deviation 8.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -9.0 swollen joint count | Standard Deviation 7.6 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 16.0 swollen joint count | Standard Deviation 9.3 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -14.0 swollen joint count | Standard Deviation 9.4 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -12.0 swollen joint count | Standard Deviation 8.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -14.0 swollen joint count | Standard Deviation 8.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -6.0 swollen joint count | Standard Deviation 6.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -13.0 swollen joint count | Standard Deviation 9.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -7.0 swollen joint count | Standard Deviation 8.1 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -15.0 swollen joint count | Standard Deviation 9.5 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 16.0 swollen joint count | Standard Deviation 9.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -15.0 swollen joint count | Standard Deviation 9.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -9.0 swollen joint count | Standard Deviation 8.3 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -16.0 swollen joint count | Standard Deviation 9.8 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -14.0 swollen joint count | Standard Deviation 9 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 16.0 swollen joint count | Standard Deviation 9.4 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -4.0 swollen joint count | Standard Deviation 7.5 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -6.0 swollen joint count | Standard Deviation 9.2 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -13.0 swollen joint count | Standard Deviation 8.8 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -14.0 swollen joint count | Standard Deviation 8.7 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -11.0 swollen joint count | Standard Deviation 8.9 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -2]Mixed effects model for repeated measure
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1, 0]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1295% CI: [-1, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.01995% CI: [-1, 0]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03295% CI: [-1, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, 0]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -21 tender joint count | Standard Deviation 12.6 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 26 tender joint count | Standard Deviation 14.5 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -20 tender joint count | Standard Deviation 12.5 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -13 tender joint count | Standard Deviation 12.1 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -22 tender joint count | Standard Deviation 12.4 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -18 tender joint count | Standard Deviation 12.5 |
| Filgotinib 200 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -9 tender joint count | Standard Deviation 10.2 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -17 tender joint count | Standard Deviation 12.4 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -20 tender joint count | Standard Deviation 13 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -21 tender joint count | Standard Deviation 13 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -8 tender joint count | Standard Deviation 9.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -21 tender joint count | Standard Deviation 12.8 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -12 tender joint count | Standard Deviation 10.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 25 tender joint count | Standard Deviation 13.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -13 tender joint count | Standard Deviation 11.8 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 26 tender joint count | Standard Deviation 13.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -9 tender joint count | Standard Deviation 11.2 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -18 tender joint count | Standard Deviation 12.4 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -22 tender joint count | Standard Deviation 12.4 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -23 tender joint count | Standard Deviation 11.9 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -23 tender joint count | Standard Deviation 12.3 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -5 tender joint count | Standard Deviation 9.8 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -21 tender joint count | Standard Deviation 12.6 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -21 tender joint count | Standard Deviation 12.7 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 26 tender joint count | Standard Deviation 13.8 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -8 tender joint count | Standard Deviation 11.5 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -19 tender joint count | Standard Deviation 12.9 |
| MTX Monotherapy | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -15 tender joint count | Standard Deviation 12.2 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6, -3]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6, -2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6, -3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -3]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6, -2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00595% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.06395% CI: [-2, 0]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.6495% CI: [-1, 1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.09595% CI: [-2, 0]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 4.1 score on a scale | Standard Deviation 9.32 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Baseline | 44.6 score on a scale | Standard Deviation 10.6 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 5.3 score on a scale | Standard Deviation 10 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 5.4 score on a scale | Standard Deviation 10.45 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 6.5 score on a scale | Standard Deviation 10.68 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 6.2 score on a scale | Standard Deviation 10.74 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 6.8 score on a scale | Standard Deviation 11.47 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 6.6 score on a scale | Standard Deviation 10.89 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Baseline | 43.2 score on a scale | Standard Deviation 11.47 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 5.7 score on a scale | Standard Deviation 10.04 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 3.6 score on a scale | Standard Deviation 8.93 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 7.3 score on a scale | Standard Deviation 11.17 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 4.5 score on a scale | Standard Deviation 9.59 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 5.5 score on a scale | Standard Deviation 10.87 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 5.8 score on a scale | Standard Deviation 11.26 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 6.1 score on a scale | Standard Deviation 11.26 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 5.4 score on a scale | Standard Deviation 11.66 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Baseline | 43.1 score on a scale | Standard Deviation 11.27 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Baseline | 43.5 score on a scale | Standard Deviation 11.5 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | 6.2 score on a scale | Standard Deviation 10.96 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | 6.5 score on a scale | Standard Deviation 11.11 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | 6.0 score on a scale | Standard Deviation 10.95 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | 1.9 score on a scale | Standard Deviation 9.22 |
| MTX Monotherapy | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | 4.5 score on a scale | Standard Deviation 10.26 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.6, 3.8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03295% CI: [0.1, 2.9]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1, 3.8]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02395% CI: [0.2, 2.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.06595% CI: [-0.1, 2.8]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1595% CI: [-0.4, 2.5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.7395% CI: [-1, 1.5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3795% CI: [-0.8, 2.2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.8395% CI: [-1.7, 1.4]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07395% CI: [-0.1, 2.5]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.0995% CI: [-0.2, 2.9]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.6895% CI: [-1.9, 1.2]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.395% CI: [-0.6, 2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.6995% CI: [-1.3, 1.9]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.9595% CI: [-1.7, 1.5]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Baseline | 33.9 score on a scale | Standard Deviation 7.48 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 12.4 score on a scale | Standard Deviation 9.3 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 6.8 score on a scale | Standard Deviation 6.86 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 13.4 score on a scale | Standard Deviation 9.62 |
| Filgotinib 200 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 11.2 score on a scale | Standard Deviation 8.66 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 12.0 score on a scale | Standard Deviation 8.47 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Baseline | 33.7 score on a scale | Standard Deviation 8 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 5.3 score on a scale | Standard Deviation 6.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.7 score on a scale | Standard Deviation 8.52 |
| Filgotinib 100 mg + MTX | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 9.1 score on a scale | Standard Deviation 8.82 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.9 score on a scale | Standard Deviation 9.22 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 8.9 score on a scale | Standard Deviation 9.17 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.2 score on a scale | Standard Deviation 8.54 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Baseline | 33.6 score on a scale | Standard Deviation 7.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 5.9 score on a scale | Standard Deviation 7.53 |
| MTX Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Baseline | 33.3 score on a scale | Standard Deviation 7.28 |
| MTX Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 36 | 11.3 score on a scale | Standard Deviation 9.04 |
| MTX Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 12 | 7.6 score on a scale | Standard Deviation 7.64 |
| MTX Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 52 | 11.2 score on a scale | Standard Deviation 9.49 |
| MTX Monotherapy | Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 | Change at Week 4 | 3.8 score on a scale | Standard Deviation 6.38 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.4, 4.1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00195% CI: [0.7, 2.8]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.3, 3.4]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.7, 4.8]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00895% CI: [0.5, 3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02395% CI: [0.2, 2.8]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [0.6, 2.9]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3895% CI: [-0.8, 2]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.5995% CI: [-1, 1.8]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.6, 4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1195% CI: [-0.3, 2.7]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07195% CI: [-0.17, 2.9]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -33.5 score on a scale | Standard Deviation 14.02 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -35.2 score on a scale | Standard Deviation 13.68 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -14.9 score on a scale | Standard Deviation 12.45 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 41.3 score on a scale | Standard Deviation 13.41 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -21.3 score on a scale | Standard Deviation 14.17 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -29.2 score on a scale | Standard Deviation 14.05 |
| Filgotinib 200 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -32.7 score on a scale | Standard Deviation 13.83 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -12.9 score on a scale | Standard Deviation 10.84 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -19.0 score on a scale | Standard Deviation 12.58 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 41.0 score on a scale | Standard Deviation 13.53 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -31.1 score on a scale | Standard Deviation 14.09 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -32.1 score on a scale | Standard Deviation 13.61 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -27.1 score on a scale | Standard Deviation 13.59 |
| Filgotinib 100 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -33.0 score on a scale | Standard Deviation 13.12 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -35.0 score on a scale | Standard Deviation 12.69 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -15.0 score on a scale | Standard Deviation 12.82 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 41.8 score on a scale | Standard Deviation 13.09 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -32.7 score on a scale | Standard Deviation 13.14 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -28.6 score on a scale | Standard Deviation 14.02 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -19.6 score on a scale | Standard Deviation 13.38 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -33.9 score on a scale | Standard Deviation 12.67 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 52 | -32.0 score on a scale | Standard Deviation 14.14 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Baseline | 41.9 score on a scale | Standard Deviation 13.39 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 2 | -8.6 score on a scale | Standard Deviation 11.49 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 4 | -13.7 score on a scale | Standard Deviation 12.83 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 12 | -23.5 score on a scale | Standard Deviation 13.82 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 36 | -32.3 score on a scale | Standard Deviation 13.47 |
| MTX Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 | Change at Week 24 | -29.0 score on a scale | Standard Deviation 14.09 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.5, -5.2]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.3, -3.3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.8, -4.7]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.9, -6.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.2, -4.1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.5, -4.5]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8, -5.1]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.5, -3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.4, -3.8]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.9, -3.4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.6, -1.6]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.9, -1.9]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3.8, -1.4]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.2395% CI: [-2.4, 0.6]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00595% CI: [-3.6, -0.6]MMRM
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2.6]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02195% CI: [-3.1, -0.3]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.3, -1.4]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline | 1.52 score on a scale | Standard Deviation 0.622 |
| Filgotinib 200 mg + MTX | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Change at Week 24 | -0.94 score on a scale | Standard Deviation 0.722 |
| Filgotinib 100 mg + MTX | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Change at Week 24 | -0.90 score on a scale | Standard Deviation 0.675 |
| Filgotinib 100 mg + MTX | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline | 1.56 score on a scale | Standard Deviation 0.654 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline | 1.56 score on a scale | Standard Deviation 0.655 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Change at Week 24 | -0.89 score on a scale | Standard Deviation 0.631 |
| MTX Monotherapy | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline | 1.60 score on a scale | Standard Deviation 0.625 |
| MTX Monotherapy | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Change at Week 24 | -0.79 score on a scale | Standard Deviation 0.634 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.27, -0.11]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00995% CI: [-0.23, -0.03]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03295% CI: [-0.2, -0.01]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 11.35 score on a scale | Standard Deviation 19.922 |
| Filgotinib 200 mg + MTX | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Change at Week 24 | 0.21 score on a scale | Standard Deviation 1.684 |
| Filgotinib 100 mg + MTX | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Change at Week 24 | 0.22 score on a scale | Standard Deviation 1.526 |
| Filgotinib 100 mg + MTX | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 13.31 score on a scale | Standard Deviation 26.98 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 16.53 score on a scale | Standard Deviation 32.372 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Change at Week 24 | -0.04 score on a scale | Standard Deviation 1.71 |
| MTX Monotherapy | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 13.72 score on a scale | Standard Deviation 29.168 |
| MTX Monotherapy | Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 | Change at Week 24 | 0.51 score on a scale | Standard Deviation 2.887 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.06895% CI: [-0.61, 0.02]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1495% CI: [-0.67, 0.1]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [-0.94, -0.16]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in the mTSS at Week 52 | Baseline | 11.31 score on a scale | Standard Deviation 19.273 |
| Filgotinib 200 mg + MTX | Change From Baseline in the mTSS at Week 52 | Change at Week 52 | 0.31 score on a scale | Standard Deviation 1.808 |
| Filgotinib 100 mg + MTX | Change From Baseline in the mTSS at Week 52 | Change at Week 52 | 0.23 score on a scale | Standard Deviation 1.111 |
| Filgotinib 100 mg + MTX | Change From Baseline in the mTSS at Week 52 | Baseline | 12.76 score on a scale | Standard Deviation 24.363 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the mTSS at Week 52 | Baseline | 15.89 score on a scale | Standard Deviation 31.813 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in the mTSS at Week 52 | Change at Week 52 | 0.33 score on a scale | Standard Deviation 1.902 |
| MTX Monotherapy | Change From Baseline in the mTSS at Week 52 | Baseline | 13.36 score on a scale | Standard Deviation 27.736 |
| MTX Monotherapy | Change From Baseline in the mTSS at Week 52 | Change at Week 52 | 0.81 score on a scale | Standard Deviation 3.089 |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.03, -0.27]MMRM
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00895% CI: [-1.09, -0.16]MMRM
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [-1.14, -0.19]MMRM
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -35.6 percentage of activity impairment | Standard Deviation 26.52 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -19.9 percentage of activity impairment | Standard Deviation 24.07 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -36.7 percentage of activity impairment | Standard Deviation 27.11 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -29.4 percentage of activity impairment | Standard Deviation 27.15 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -33.1 percentage of activity impairment | Standard Deviation 26.84 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 60.2 percentage of activity impairment | Standard Deviation 23.36 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -15.8 percentage of activity impairment | Standard Deviation 23.9 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 62.8 percentage of activity impairment | Standard Deviation 23.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -26.4 percentage of activity impairment | Standard Deviation 26.19 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -33.8 percentage of activity impairment | Standard Deviation 26.48 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -35.4 percentage of activity impairment | Standard Deviation 28.32 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -33.2 percentage of activity impairment | Standard Deviation 26.97 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 63.3 percentage of activity impairment | Standard Deviation 24.37 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -17.8 percentage of activity impairment | Standard Deviation 27.11 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -34.1 percentage of activity impairment | Standard Deviation 28.26 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -31.2 percentage of activity impairment | Standard Deviation 28.01 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -36.7 percentage of activity impairment | Standard Deviation 28.37 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -28.7 percentage of activity impairment | Standard Deviation 27.8 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -34.2 percentage of activity impairment | Standard Deviation 28.83 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 64.0 percentage of activity impairment | Standard Deviation 22.59 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -12.4 percentage of activity impairment | Standard Deviation 23.8 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -22.7 percentage of activity impairment | Standard Deviation 25.32 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -31.5 percentage of activity impairment | Standard Deviation 27.8 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -32.1 percentage of activity impairment | Standard Deviation 28.47 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -29.1 percentage of impairment while working | Standard Deviation 24.99 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -17.8 percentage of impairment while working | Standard Deviation 25.34 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -32.3 percentage of impairment while working | Standard Deviation 26.81 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -25.6 percentage of impairment while working | Standard Deviation 27.09 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -27.1 percentage of impairment while working | Standard Deviation 26.77 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 47.3 percentage of impairment while working | Standard Deviation 26.32 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -28.4 percentage of impairment while working | Standard Deviation 29.39 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -33.8 percentage of impairment while working | Standard Deviation 27.99 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -32.9 percentage of impairment while working | Standard Deviation 28.2 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -32.7 percentage of impairment while working | Standard Deviation 31.75 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 49.0 percentage of impairment while working | Standard Deviation 28.45 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -19.8 percentage of impairment while working | Standard Deviation 27.49 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -30.3 percentage of impairment while working | Standard Deviation 29.38 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -18.3 percentage of impairment while working | Standard Deviation 28.58 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -27.9 percentage of impairment while working | Standard Deviation 27.06 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -26.0 percentage of impairment while working | Standard Deviation 24.7 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 52.1 percentage of impairment while working | Standard Deviation 25.81 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -33.3 percentage of impairment while working | Standard Deviation 29.25 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -31.5 percentage of impairment while working | Standard Deviation 28.23 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 53.6 percentage of impairment while working | Standard Deviation 27.12 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -7.4 percentage of impairment while working | Standard Deviation 20.55 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -20.7 percentage of impairment while working | Standard Deviation 27.83 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -28.3 percentage of impairment while working | Standard Deviation 29.06 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -28.8 percentage of impairment while working | Standard Deviation 31.92 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -28.5 percentage of overall work productivity | Standard Deviation 27.71 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -29.3 percentage of overall work productivity | Standard Deviation 26.76 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -33.0 percentage of overall work productivity | Standard Deviation 28.74 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -17.6 percentage of overall work productivity | Standard Deviation 26.21 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 50.8 percentage of overall work productivity | Standard Deviation 27.28 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -26.3 percentage of overall work productivity | Standard Deviation 28.85 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -33.1 percentage of overall work productivity | Standard Deviation 31.56 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -31.3 percentage of overall work productivity | Standard Deviation 30.04 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 51.6 percentage of overall work productivity | Standard Deviation 30.1 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -19.0 percentage of overall work productivity | Standard Deviation 29.43 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -33.5 percentage of overall work productivity | Standard Deviation 32.34 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -27.5 percentage of overall work productivity | Standard Deviation 30.53 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -23.5 percentage of overall work productivity | Standard Deviation 26.01 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 54.4 percentage of overall work productivity | Standard Deviation 25.6 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -17.6 percentage of overall work productivity | Standard Deviation 28.69 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -24.7 percentage of overall work productivity | Standard Deviation 29.61 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -29.1 percentage of overall work productivity | Standard Deviation 31.79 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -30.6 percentage of overall work productivity | Standard Deviation 31.24 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -30.8 percentage of overall work productivity | Standard Deviation 28.76 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -29.2 percentage of overall work productivity | Standard Deviation 32.72 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Baseline | 56.1 percentage of overall work productivity | Standard Deviation 28 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -20.1 percentage of overall work productivity | Standard Deviation 28.63 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -27.9 percentage of overall work productivity | Standard Deviation 29.31 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -6.4 percentage of overall work productivity | Standard Deviation 22.27 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -4.8 percentage of work time missed | Standard Deviation 23.27 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -4.9 percentage of work time missed | Standard Deviation 25.11 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -6.7 percentage of work time missed | Standard Deviation 28.2 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -4.8 percentage of work time missed | Standard Deviation 28.91 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 12.8 percentage of work time missed | Standard Deviation 24.29 |
| Filgotinib 200 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -1.5 percentage of work time missed | Standard Deviation 25.68 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -16.4 percentage of work time missed | Standard Deviation 35.63 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -15.7 percentage of work time missed | Standard Deviation 32.72 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -3.3 percentage of work time missed | Standard Deviation 24.44 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -11.0 percentage of work time missed | Standard Deviation 32.65 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -15.5 percentage of work time missed | Standard Deviation 34.51 |
| Filgotinib 100 mg + MTX | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 20.1 percentage of work time missed | Standard Deviation 32.36 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -2.8 percentage of work time missed | Standard Deviation 29.12 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 13.5 percentage of work time missed | Standard Deviation 26.35 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -4.1 percentage of work time missed | Standard Deviation 26.83 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -4.0 percentage of work time missed | Standard Deviation 21.08 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -3.1 percentage of work time missed | Standard Deviation 28.77 |
| Filgotinib 200 mg Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -2.3 percentage of work time missed | Standard Deviation 23.52 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 52 | -6.7 percentage of work time missed | Standard Deviation 31.63 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 4 | -1.3 percentage of work time missed | Standard Deviation 23.73 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 12 | -5.2 percentage of work time missed | Standard Deviation 29.01 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 24 | -10.6 percentage of work time missed | Standard Deviation 29.08 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Change at Week 36 | -7.9 percentage of work time missed | Standard Deviation 29.99 |
| MTX Monotherapy | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Baseline | 15.6 percentage of work time missed | Standard Deviation 28.79 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 36 | 73 score on a scale | Standard Deviation 22.1 |
| Filgotinib 200 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 52 | 75 score on a scale | Standard Deviation 21.7 |
| Filgotinib 200 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 12 | 69 score on a scale | Standard Deviation 21.3 |
| Filgotinib 200 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 24 | 73 score on a scale | Standard Deviation 21 |
| Filgotinib 200 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 4 | 65 score on a scale | Standard Deviation 18.7 |
| Filgotinib 100 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 12 | 67 score on a scale | Standard Deviation 22.9 |
| Filgotinib 100 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 4 | 61 score on a scale | Standard Deviation 21.6 |
| Filgotinib 100 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 36 | 71 score on a scale | Standard Deviation 21.8 |
| Filgotinib 100 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 52 | 72 score on a scale | Standard Deviation 22.1 |
| Filgotinib 100 mg + MTX | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 24 | 72 score on a scale | Standard Deviation 19.6 |
| Filgotinib 200 mg Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 52 | 71 score on a scale | Standard Deviation 23.7 |
| Filgotinib 200 mg Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 36 | 69 score on a scale | Standard Deviation 21.1 |
| Filgotinib 200 mg Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 12 | 66 score on a scale | Standard Deviation 22.7 |
| Filgotinib 200 mg Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 24 | 68 score on a scale | Standard Deviation 22.4 |
| Filgotinib 200 mg Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 4 | 62 score on a scale | Standard Deviation 20 |
| MTX Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 12 | 64 score on a scale | Standard Deviation 20.7 |
| MTX Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 4 | 56 score on a scale | Standard Deviation 21.2 |
| MTX Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 52 | 71 score on a scale | Standard Deviation 21.2 |
| MTX Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 24 | 69 score on a scale | Standard Deviation 21.3 |
| MTX Monotherapy | EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 | Week 36 | 68 score on a scale | Standard Deviation 22.8 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 40.2 score on a scale | Standard Deviation 9.36 |
| Filgotinib 200 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 39.8 score on a scale | Standard Deviation 9.58 |
| Filgotinib 200 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 38.1 score on a scale | Standard Deviation 10.21 |
| Filgotinib 200 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 39.1 score on a scale | Standard Deviation 10.13 |
| Filgotinib 200 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 35.2 score on a scale | Standard Deviation 9.82 |
| Filgotinib 100 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 36.6 score on a scale | Standard Deviation 11.26 |
| Filgotinib 100 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 38.9 score on a scale | Standard Deviation 10.19 |
| Filgotinib 100 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 38.7 score on a scale | Standard Deviation 9.88 |
| Filgotinib 100 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 38.7 score on a scale | Standard Deviation 10.11 |
| Filgotinib 100 mg + MTX | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 34.1 score on a scale | Standard Deviation 10.75 |
| Filgotinib 200 mg Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 37.9 score on a scale | Standard Deviation 10.76 |
| Filgotinib 200 mg Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 38.8 score on a scale | Standard Deviation 10.17 |
| Filgotinib 200 mg Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 36.9 score on a scale | Standard Deviation 11.16 |
| Filgotinib 200 mg Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 34.2 score on a scale | Standard Deviation 10.52 |
| Filgotinib 200 mg Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 39.7 score on a scale | Standard Deviation 10.96 |
| MTX Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 38.4 score on a scale | Standard Deviation 9.91 |
| MTX Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 38.1 score on a scale | Standard Deviation 9.86 |
| MTX Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 31.4 score on a scale | Standard Deviation 10.87 |
| MTX Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 35.3 score on a scale | Standard Deviation 10.23 |
| MTX Monotherapy | FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 37.3 score on a scale | Standard Deviation 10.62 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Moderate Problems | 48 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Severe Problems | 9 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | No Problems | 277 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | No Problems | 199 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Slight Problems | 208 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Moderate Problems | 132 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | No Problems | 93 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Severe Problems | 12 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 6 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Moderate Problems | 28 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Slight Problems | 97 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 222 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | No Problems | 161 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Slight Problems | 149 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Moderate Problems | 82 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Severe Problems | 13 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | No Problems | 198 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Slight Problems | 135 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Moderate Problems | 41 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Severe Problems | 12 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | No Problems | 208 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Slight Problems | 116 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Moderate Problems | 46 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Severe Problems | 5 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | No Problems | 216 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Slight Problems | 96 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | No Problems | 217 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Slight Problems | 92 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Moderate Problems | 28 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | No Problems | 214 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Slight Problems | 142 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Moderate Problems | 42 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Severe Problems | 7 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Slight Problems | 85 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Moderate Problems | 19 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Severe Problems | 6 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | No Problems | 283 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Slight Problems | 73 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Moderate Problems | 16 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Severe Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | No Problems | 271 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Slight Problems | 70 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Moderate Problems | 20 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Severe Problems | 3 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | No Problems | 268 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Slight Problems | 60 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Moderate Problems | 13 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | No Problems | 118 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Slight Problems | 180 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Moderate Problems | 90 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Severe Problems | 16 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | No Problems | 185 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Slight Problems | 148 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Moderate Problems | 44 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Severe Problems | 11 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | No Problems | 188 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Slight Problems | 135 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Moderate Problems | 43 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Slight Problems | 119 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 42 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | No Problems | 203 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Slight Problems | 106 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 31 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Severe Problems | 7 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | No Problems | 45 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Severe Problems | 21 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Slight Problems | 202 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Moderate Problems | 83 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | No Problems | 110 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Slight Problems | 182 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Moderate Problems | 75 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 102 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 188 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 68 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 108 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 169 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 59 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 11 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | No Problems | 221 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Slight Problems | 126 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Moderate Problems | 53 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Severe Problems | 6 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | No Problems | 233 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Slight Problems | 114 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Severe Problems | 14 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | No Problems | 236 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Moderate Problems | 32 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 233 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 99 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 31 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 2 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 94 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 26 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 200 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | No Problems | 93 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Moderate Problems | 47 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Slight Problems | 55 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Moderate Problems | 46 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Slight Problems | 50 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Severe Problems | 19 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Severe Problems | 17 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 18 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Slight Problems | 91 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 14 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | No Problems | 46 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Extreme Problems | 3 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | No Problems | 78 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Moderate Problems | 22 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Slight Problems | 62 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Slight Problems | 65 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Severe Problems | 15 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Moderate Problems | 47 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Moderate Problems | 42 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Moderate Problems | 36 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Moderate Problems | 19 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | No Problems | 91 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Slight Problems | 96 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Severe Problems | 5 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Moderate Problems | 25 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | No Problems | 35 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | No Problems | 92 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Severe Problems | 19 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Slight Problems | 60 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | No Problems | 101 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Moderate Problems | 73 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Moderate Problems | 31 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Slight Problems | 85 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | No Problems | 23 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 46 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Slight Problems | 56 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Severe Problems | 7 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | No Problems | 86 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | No Problems | 99 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 22 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 40 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Slight Problems | 61 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | No Problems | 128 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | No Problems | 117 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Moderate Problems | 30 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Slight Problems | 62 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Severe Problems | 4 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 41 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | No Problems | 84 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | No Problems | 87 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Slight Problems | 42 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Moderate Problems | 20 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Severe Problems | 17 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Slight Problems | 58 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Severe Problems | 2 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Slight Problems | 63 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Moderate Problems | 50 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Moderate Problems | 36 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 90 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Slight Problems | 68 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | No Problems | 122 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 8 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | No Problems | 66 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Moderate Problems | 28 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Slight Problems | 44 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Moderate Problems | 29 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 13 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Moderate Problems | 33 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Moderate Problems | 21 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Slight Problems | 55 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 50 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Severe Problems | 1 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 119 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Slight Problems | 60 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Severe Problems | 3 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Slight Problems | 47 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | No Problems | 117 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 43 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Severe Problems | 10 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Slight Problems | 36 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | No Problems | 104 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Extreme Problems | 3 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 40 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 113 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Severe Problems | 2 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Severe Problems | 6 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | No Problems | 92 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | No Problems | 113 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | No Problems | 50 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 82 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 37 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Moderate Problems | 21 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Slight Problems | 86 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg + MTX | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Moderate Problems | 11 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | No Problems | 93 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 88 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Slight Problems | 47 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 17 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Moderate Problems | 21 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Severe Problems | 10 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 25 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | No Problems | 102 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Slight Problems | 50 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Moderate Problems | 38 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 9 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Severe Problems | 10 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | No Problems | 111 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Slight Problems | 55 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Moderate Problems | 21 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Severe Problems | 4 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | No Problems | 94 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | No Problems | 112 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Slight Problems | 52 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Moderate Problems | 17 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Severe Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Slight Problems | 64 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | No Problems | 121 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Slight Problems | 41 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Moderate Problems | 16 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Moderate Problems | 35 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Severe Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | No Problems | 117 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Slight Problems | 36 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Moderate Problems | 16 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Severe Problems | 4 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | No Problems | 54 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Slight Problems | 81 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 106 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Moderate Problems | 49 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | No Problems | 106 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Severe Problems | 14 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | No Problems | 83 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Slight Problems | 61 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Moderate Problems | 35 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Severe Problems | 11 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Moderate Problems | 17 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | No Problems | 83 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Slight Problems | 63 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Moderate Problems | 30 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | No Problems | 92 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Slight Problems | 51 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 31 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Severe Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | No Problems | 92 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 43 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Slight Problems | 48 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 27 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | No Problems | 103 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Slight Problems | 64 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | No Problems | 21 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Severe Problems | 26 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | No Problems | 38 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Slight Problems | 81 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Moderate Problems | 53 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Severe Problems | 16 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Severe Problems | 6 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | No Problems | 40 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Slight Problems | 93 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Moderate Problems | 42 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Slight Problems | 91 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Severe Problems | 7 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Moderate Problems | 60 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 44 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 7 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Severe Problems | 6 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Slight Problems | 58 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 20 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Severe Problems | 10 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 39 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | No Problems | 81 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 103 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Slight Problems | 56 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Moderate Problems | 38 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 87 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Severe Problems | 20 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Extreme Problems | 6 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | No Problems | 86 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Slight Problems | 60 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Moderate Problems | 27 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Severe Problems | 14 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Extreme Problems | 5 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 56 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | No Problems | 95 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Slight Problems | 50 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Moderate Problems | 24 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Severe Problems | 13 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 49 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | No Problems | 98 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Slight Problems | 46 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Moderate Problems | 27 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Severe Problems | 8 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | No Problems | 152 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Slight Problems | 206 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Severe Problems | 20 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Severe Problems | 49 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Moderate Problems | 122 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Severe Problems | 13 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Slight Problems | 153 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Extreme Problems | 5 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | No Problems | 101 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 18 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | No Problems | 190 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Moderate Problems | 98 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | No Problems | 80 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 63 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 50 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Extreme Problems | 4 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Moderate Problems | 54 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Severe Problems | 6 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Severe Problems | 22 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | Extreme Problems | 0 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | No Problems | 152 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Severe Problems | 29 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Moderate Problems | 96 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 168 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Moderate Problems | 35 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 22 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Severe Problems | 25 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Slight Problems | 135 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | Slight Problems | 84 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Slight Problems | 135 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | Slight Problems | 141 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 52 | No Problems | 208 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Moderate Problems | 42 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Extreme Problems | 3 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Moderate Problems | 73 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Severe Problems | 5 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 194 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Moderate Problems | 31 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | Slight Problems | 93 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 32 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Slight Problems | 108 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 12 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Moderate Problems | 63 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 116 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 57 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 36 | No Problems | 224 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 4 | No Problems | 143 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | No Problems | 104 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Severe Problems | 16 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | Slight Problems | 148 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Severe Problems | 16 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Slight Problems | 135 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Severe Problems | 5 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 80 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Moderate Problems | 116 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Moderate Problems | 46 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Moderate Problems | 51 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Severe Problems | 12 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 4 | Severe Problems | 54 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | No Problems | 147 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 195 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 50 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | Slight Problems | 95 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Slight Problems | 125 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | Slight Problems | 134 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 36 | No Problems | 158 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 24 | Extreme Problems | 4 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 45 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Extreme Problems | 4 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 4 | No Problems | 159 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Severe Problems | 10 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | No Problems | 219 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Severe Problems | 13 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | No Problems | 156 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | No Problems | 138 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Severe Problems | 15 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 24 | No Problems | 222 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | No Problems | 18 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Moderate Problems | 64 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Slight Problems | 131 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | Slight Problems | 147 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Moderate Problems | 173 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Slight Problems | 93 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 5 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Severe Problems | 78 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 100 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 24 | No Problems | 142 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 52 | Severe Problems | 15 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 4 | Extreme Problems | 10 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Moderate Problems | 49 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Slight Problems | 135 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | No Problems | 41 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Extreme Problems | 4 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Severe Problems | 19 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 85 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Slight Problems | 167 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Moderate Problems | 85 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | Slight Problems | 125 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Moderate Problems | 54 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Moderate Problems | 143 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 12 | Slight Problems | 179 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 36 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Severe Problems | 35 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 182 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Mobility: Week 12 | Moderate Problems | 91 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 12 | Extreme Problems | 2 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 1 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Usual Activities: Week 4 | Extreme Problems | 6 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Self-Care: Week 12 | Slight Problems | 129 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Pain/Discomfort: Week 24 | No Problems | 44 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 24 | Severe Problems | 14 Participants |
| MTX Monotherapy | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 | Anxiety/Depression: Week 12 | No Problems | 198 Participants |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | No Response | 26 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Moderate Response | 130 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Moderate Response | 206 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | No Response | 3 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Good Response | 230 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | No Response | 77 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | No Response | 7 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Moderate Response | 64 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Moderate Response | 199 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Good Response | 286 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Good Response | 276 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | No Response | 9 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | No Response | 134 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Moderate Response | 43 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Moderate Response | 82 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Good Response | 283 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Good Response | 120 Participants |
| Filgotinib 200 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Good Response | 66 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Good Response | 123 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Good Response | 21 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Moderate Response | 92 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | No Response | 86 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Good Response | 45 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Moderate Response | 104 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | No Response | 50 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Good Response | 100 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Moderate Response | 79 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | No Response | 16 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Good Response | 127 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Moderate Response | 55 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | No Response | 8 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Good Response | 118 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Moderate Response | 54 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | No Response | 5 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Moderate Response | 43 Participants |
| Filgotinib 100 mg + MTX | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | No Response | 4 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | No Response | 14 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Good Response | 126 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | No Response | 77 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | No Response | 3 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Moderate Response | 52 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Moderate Response | 30 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | No Response | 5 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Moderate Response | 88 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Good Response | 124 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Moderate Response | 51 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Good Response | 35 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | No Response | 2 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Moderate Response | 97 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Good Response | 98 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | No Response | 42 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Moderate Response | 77 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Good Response | 63 Participants |
| Filgotinib 200 mg Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Good Response | 136 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Moderate Response | 190 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | No Response | 258 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Good Response | 194 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | Good Response | 116 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Good Response | 186 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Moderate Response | 106 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | No Response | 74 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | No Response | 11 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | Moderate Response | 153 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Moderate Response | 118 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Good Response | 45 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | Moderate Response | 161 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | No Response | 29 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | No Response | 7 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | Moderate Response | 102 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | No Response | 195 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | Good Response | 208 Participants |
| MTX Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | Good Response | 20 Participants |
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 12 | 76.7 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 36 | 75.5 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 52 | 75.0 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 4 | 62.3 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 2 | 42.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 4 | 55.6 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 12 | 72.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 2 | 37.2 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 36 | 73.4 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 52 | 73.4 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 52 | 74.8 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 2 | 39.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 4 | 52.4 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 12 | 71.4 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 36 | 76.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 4 | 33.4 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 36 | 68.3 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 2 | 16.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 52 | 61.8 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 | Week 12 | 59.4 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [6.7, 19.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.00395% CI: [3.7, 19.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [5.1, 20.8]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [19.3, 31.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [12.8, 28.5]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [15.1, 30.8]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [22.1, 35.6]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [13.6, 30.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [10.5, 27.5]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [10.8, 23.8]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: 0.00295% CI: [4.5, 20.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: 0.00295% CI: [4, 20.1]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.01695% CI: [0.9, 13.5]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.1895% CI: [-2.7, 13]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36p-value: 0.0395% CI: [0.3, 15.6]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 13.0 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 61.5 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 60.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 29.3 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 62.3 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 53.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 44.4 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 20.8 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 57.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 9.2 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 59.4 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 55.6 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 58.1 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 45.7 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 61.4 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 25.7 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 58.6 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 16.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 48.3 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 2.9 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 9.4 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 28.4 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 45.7 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 48.6 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [6.2, 13.9]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2p-value: 0.00195% CI: [1.7, 10.9]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [7.7, 18.9]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [14.5, 25.4]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [4.8, 18]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [9.4, 23.2]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [18.1, 31.5]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [7.7, 24.5]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [9, 25.7]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [8.9, 22.8]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: 0.00695% CI: [2.7, 20]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: 0.00295% CI: [3.9, 21]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36p-value: <0.00195% CI: [5.1, 19]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.0995% CI: [-1.7, 15.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36p-value: 0.01495% CI: [1.4, 18.6]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [7, 20.9]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.00895% CI: [2.5, 19.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: 0.00195% CI: [4.6, 21.6]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 47.8 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 32.9 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 13.0 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 45.9 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 43.8 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 3.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 6.3 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 40.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 1.9 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 37.2 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 27.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 40.1 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 4.3 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 39.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 45.2 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 40.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 11.4 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 29.0 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 29.8 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 3.8 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 13.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 26.0 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 32.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 0.7 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2p-value: 0.01895% CI: [0.3, 4.5]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2p-value: 0.1795% CI: [-1.2, 3.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2p-value: 0.00495% CI: [0.3, 6.8]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [5.2, 13.1]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: 0.1895% CI: [-1.7, 6.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [2.5, 12.6]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [13.9, 25.5]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [6.6, 21.1]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [8.5, 23.1]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [11.2, 24.4]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [5.9, 22.4]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [5.8, 22.2]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36p-value: <0.00195% CI: [6.9, 20.5]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.295% CI: [-3.3, 13.3]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36p-value: 0.05695% CI: [-1, 15.7]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [11.3, 24.8]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.0195% CI: [1.9, 18.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [7, 23.8]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 72.4 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 61.9 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 80.3 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 70.9 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 73.4 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 76.6 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 74.5 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 58.5 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 61.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 78.5 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 76.5 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 71.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 73.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 77.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 74.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 53.9 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 68.6 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 70.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 12 | 69.8 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 52 | 61.0 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 24 | 73.9 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 36 | 67.1 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 4 | 53.9 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 | Week 2 | 42.2 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [12.8, 26.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [7.6, 25]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2p-value: 0.00495% CI: [3, 20.4]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [11.7, 25.2]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: 0.08395% CI: [-1.6, 15.8]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [6.4, 23.1]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [4.4, 16.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: 0.2295% CI: [-3.1, 12.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: 0.2595% CI: [-3.6, 12.1]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: 0.3595% CI: [-3.5, 8.9]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: 0.295% CI: [-2.9, 12.1]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: 0.3695% CI: [-4.5, 10.6]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.04395% CI: [-0.2, 12.8]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.01595% CI: [1.6, 17.2]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36p-value: 0.08595% CI: [-1.5, 14.4]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.00295% CI: [3.2, 16.6]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.0195% CI: [2.3, 18.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: 0.01495% CI: [1.4, 17.8]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 12 | 39.7 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 4 | 16.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 52 | 53.4 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 36 | 52.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 2 | 7.2 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 36 | 42.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 52 | 43.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 4 | 15.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 12 | 31.9 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 2 | 4.3 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 52 | 46.2 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 12 | 29.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 2 | 10.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 4 | 19.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 36 | 43.3 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 52 | 31.5 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 4 | 4.8 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 12 | 17.1 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 36 | 34.4 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 | Week 2 | 1.0 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [15.1, 28.7]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [3.4, 9.1]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2p-value: 0.0195% CI: [0.1, 6.7]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2p-value: <0.00195% CI: [4.5, 13.6]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [7.4, 16.1]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [4.5, 15.8]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [8.6, 20.8]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [16.4, 28.8]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [7.1, 22.5]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [4.9, 20]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36p-value: <0.00195% CI: [11.4, 25.1]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36p-value: 0.05695% CI: [-0.8, 16.1]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36p-value: 0.02395% CI: [0.5, 17.4]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.00495% CI: [3.1, 20]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [6.3, 23.1]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 52 | 69.0 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 24 | 68.8 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 12 | 55.8 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 4 | 30.8 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 4 | 23.7 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 12 | 50.2 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 24 | 62.8 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 52 | 59.9 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 4 | 31.9 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 24 | 60.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 12 | 48.1 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 52 | 65.7 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 12 | 28.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 24 | 46.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 52 | 47.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 | Week 4 | 12.0 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [13.1, 24.4]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [4.7, 18.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4p-value: <0.00195% CI: [12.5, 27.3]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [20.5, 33.9]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [13.2, 30.1]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12p-value: <0.00195% CI: [11.1, 27.9]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [15.8, 29.4]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [8.1, 25.2]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [5.3, 22.4]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [14.6, 28.2]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52p-value: 0.00395% CI: [3.7, 20.9]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52p-value: <0.00195% CI: [9.7, 26.5]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg + MTX | 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 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 | 42.5 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 | 42.4 percentage of participants |
| 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 | 29.1 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [18.3, 31.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [5, 21.8]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24p-value: <0.00195% CI: [5, 21.6]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0 | 80.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ SDC (1.77) | 94.2 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0.5 | 89.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0 | 80.6 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ SDC (1.53) | 95.2 percentage of participants |
| Filgotinib 200 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0.5 | 88.1 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ SDC (1.53) | 93.5 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0.5 | 85.8 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0.5 | 87.0 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ SDC (1.77) | 94.9 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0 | 76.6 percentage of participants |
| Filgotinib 100 mg + MTX | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0 | 76.1 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ SDC (1.53) | 96.0 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0.5 | 89.6 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0 | 82.7 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0.5 | 84.3 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0 | 77.1 percentage of participants |
| Filgotinib 200 mg Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ SDC (1.77) | 89.2 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0 | 72.5 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ SDC (1.77) | 86.7 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0 | 70.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ SDC (1.53) | 91.6 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 24: Change in mTSS ≤ 0.5 | 82.0 percentage of participants |
| MTX Monotherapy | Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 | Week 52: Change in mTSS ≤ 0.5 | 77.9 percentage of participants |
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5p-value: 0.00695% CI: [2.2, 12.9]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5p-value: 0.1695% CI: [-1.8, 11.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5p-value: 0.02995% CI: [1.1, 14.1]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0p-value: 0.01595% CI: [1.6, 14.6]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0p-value: 0.3395% CI: [-3.9, 12.2]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0p-value: 0.01395% CI: [2.5, 17.9]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)p-value: 0.07495% CI: [-0.3, 7.6]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)p-value: 0.4995% CI: [-3.1, 6.9]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)p-value: 0.07595% CI: [-0.2, 8.9]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5p-value: <0.00195% CI: [4.3, 16.2]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5p-value: 0.04595% CI: [0.7, 15.2]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5p-value: 0.195% CI: [-1.1, 14]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0p-value: 0.00495% CI: [3.2, 16.7]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0p-value: 0.2595% CI: [-2.9, 14]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0p-value: 0.1495% CI: [-2, 15]Regression, Logistic
Comparison: Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)p-value: 0.00295% CI: [2.8, 12.3]Regression, Logistic
Comparison: Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)p-value: 0.00895% CI: [2.9, 13.6]Regression, Logistic
Comparison: Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)p-value: 0.4795% CI: [-3.9, 8.9]Regression, Logistic
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 50.1 score on a scale | Standard Deviation 9.61 |
| Filgotinib 200 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 50.9 score on a scale | Standard Deviation 9.32 |
| Filgotinib 200 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 48.7 score on a scale | Standard Deviation 9.73 |
| Filgotinib 200 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 51.1 score on a scale | Standard Deviation 9.38 |
| Filgotinib 200 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 49.9 score on a scale | Standard Deviation 9.49 |
| Filgotinib 100 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 50.1 score on a scale | Standard Deviation 10.34 |
| Filgotinib 100 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 49.2 score on a scale | Standard Deviation 9.99 |
| Filgotinib 100 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 50.0 score on a scale | Standard Deviation 10.08 |
| Filgotinib 100 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 46.9 score on a scale | Standard Deviation 10.42 |
| Filgotinib 100 mg + MTX | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 50.6 score on a scale | Standard Deviation 10.26 |
| Filgotinib 200 mg Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 48.8 score on a scale | Standard Deviation 10.85 |
| Filgotinib 200 mg Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 49.7 score on a scale | Standard Deviation 10 |
| Filgotinib 200 mg Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 49.1 score on a scale | Standard Deviation 9.61 |
| Filgotinib 200 mg Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 49.2 score on a scale | Standard Deviation 10.11 |
| Filgotinib 200 mg Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 47.5 score on a scale | Standard Deviation 10.46 |
| MTX Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 50.2 score on a scale | Standard Deviation 9.64 |
| MTX Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 45.5 score on a scale | Standard Deviation 11.38 |
| MTX Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 48.1 score on a scale | Standard Deviation 10.26 |
| MTX Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 49.4 score on a scale | Standard Deviation 10.25 |
| MTX Monotherapy | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 49.9 score on a scale | Standard Deviation 10.2 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 46.6 score on a scale | Standard Deviation 8.17 |
| Filgotinib 200 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 45.0 score on a scale | Standard Deviation 8.42 |
| Filgotinib 200 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 47.4 score on a scale | Standard Deviation 8.35 |
| Filgotinib 200 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 46.3 score on a scale | Standard Deviation 8.16 |
| Filgotinib 200 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 40.6 score on a scale | Standard Deviation 8.04 |
| Filgotinib 100 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 44.8 score on a scale | Standard Deviation 9.39 |
| Filgotinib 100 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 45.2 score on a scale | Standard Deviation 9.42 |
| Filgotinib 100 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 45.6 score on a scale | Standard Deviation 9.02 |
| Filgotinib 100 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 42.9 score on a scale | Standard Deviation 9.71 |
| Filgotinib 100 mg + MTX | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 39.2 score on a scale | Standard Deviation 8.86 |
| Filgotinib 200 mg Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 44.1 score on a scale | Standard Deviation 9.42 |
| Filgotinib 200 mg Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 39.6 score on a scale | Standard Deviation 8.46 |
| Filgotinib 200 mg Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 42.7 score on a scale | Standard Deviation 9.9 |
| Filgotinib 200 mg Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 45.0 score on a scale | Standard Deviation 8.89 |
| Filgotinib 200 mg Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 45.9 score on a scale | Standard Deviation 9.4 |
| MTX Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 36 | 44.4 score on a scale | Standard Deviation 8.39 |
| MTX Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 12 | 40.9 score on a scale | Standard Deviation 8.1 |
| MTX Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 4 | 37.0 score on a scale | Standard Deviation 8.13 |
| MTX Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 24 | 43.0 score on a scale | Standard Deviation 8.36 |
| MTX Monotherapy | SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 | Week 52 | 44.5 score on a scale | Standard Deviation 8.32 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 6.7 percentage of work time missed | Standard Deviation 19.11 |
| Filgotinib 200 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 6.4 percentage of work time missed | Standard Deviation 19.93 |
| Filgotinib 200 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 4.6 percentage of work time missed | Standard Deviation 14.62 |
| Filgotinib 200 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 5.5 percentage of work time missed | Standard Deviation 15.78 |
| Filgotinib 200 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 10.1 percentage of work time missed | Standard Deviation 23.95 |
| Filgotinib 100 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 15.4 percentage of work time missed | Standard Deviation 30.46 |
| Filgotinib 100 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 8.5 percentage of work time missed | Standard Deviation 20.7 |
| Filgotinib 100 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 7.3 percentage of work time missed | Standard Deviation 18.29 |
| Filgotinib 100 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 5.7 percentage of work time missed | Standard Deviation 13.96 |
| Filgotinib 100 mg + MTX | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 7.0 percentage of work time missed | Standard Deviation 17.9 |
| Filgotinib 200 mg Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 12.4 percentage of work time missed | Standard Deviation 23.14 |
| Filgotinib 200 mg Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 9.2 percentage of work time missed | Standard Deviation 21.88 |
| Filgotinib 200 mg Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 9.8 percentage of work time missed | Standard Deviation 22.21 |
| Filgotinib 200 mg Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 12.6 percentage of work time missed | Standard Deviation 24.42 |
| Filgotinib 200 mg Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 11.5 percentage of work time missed | Standard Deviation 25.28 |
| MTX Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 6.4 percentage of work time missed | Standard Deviation 19.84 |
| MTX Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 11.3 percentage of work time missed | Standard Deviation 25.59 |
| MTX Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 5.1 percentage of work time missed | Standard Deviation 14.21 |
| MTX Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 5.6 percentage of work time missed | Standard Deviation 16.9 |
| MTX Monotherapy | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 16.0 percentage of work time missed | Standard Deviation 30.49 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 23.5 percentage of activity impairment | Standard Deviation 22.54 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 30.6 percentage of activity impairment | Standard Deviation 25.53 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 22.5 percentage of activity impairment | Standard Deviation 22.8 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 26.5 percentage of activity impairment | Standard Deviation 23.32 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 40.4 percentage of activity impairment | Standard Deviation 25.52 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 29.5 percentage of activity impairment | Standard Deviation 26.02 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 29.7 percentage of activity impairment | Standard Deviation 27.03 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 28.2 percentage of activity impairment | Standard Deviation 26.54 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 36.1 percentage of activity impairment | Standard Deviation 26.77 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 46.8 percentage of activity impairment | Standard Deviation 27.82 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 32.3 percentage of activity impairment | Standard Deviation 26.92 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 45.4 percentage of activity impairment | Standard Deviation 25.65 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 34.7 percentage of activity impairment | Standard Deviation 27.29 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 29.0 percentage of activity impairment | Standard Deviation 26.08 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 25.6 percentage of activity impairment | Standard Deviation 25.19 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 31.8 percentage of activity impairment | Standard Deviation 25.55 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 41.1 percentage of activity impairment | Standard Deviation 24.75 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 51.6 percentage of activity impairment | Standard Deviation 24.73 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 32.1 percentage of activity impairment | Standard Deviation 24.44 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 28.8 percentage of activity impairment | Standard Deviation 23.81 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 15.5 percentage of impairment while working | Standard Deviation 18.38 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 29.6 percentage of impairment while working | Standard Deviation 24.21 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 14.5 percentage of impairment while working | Standard Deviation 18.08 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 22.6 percentage of impairment while working | Standard Deviation 23.43 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 17.9 percentage of impairment while working | Standard Deviation 18.95 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 29.4 percentage of impairment while working | Standard Deviation 27.76 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 19.6 percentage of impairment while working | Standard Deviation 22.32 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 23.6 percentage of impairment while working | Standard Deviation 24.85 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 16.3 percentage of impairment while working | Standard Deviation 20.31 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 18.1 percentage of impairment while working | Standard Deviation 19.4 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 16.5 percentage of impairment while working | Standard Deviation 23.08 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 23.2 percentage of impairment while working | Standard Deviation 24.7 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 20.9 percentage of impairment while working | Standard Deviation 24.04 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 33.9 percentage of impairment while working | Standard Deviation 24.1 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 26.0 percentage of impairment while working | Standard Deviation 24.78 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 52 | 18.3 percentage of impairment while working | Standard Deviation 16.95 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 4 | 45.3 percentage of impairment while working | Standard Deviation 26.04 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 24 | 23.3 percentage of impairment while working | Standard Deviation 21.18 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 36 | 22.7 percentage of impairment while working | Standard Deviation 24.1 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 | Week 12 | 32.5 percentage of impairment while working | Standard Deviation 24.31 |
Secondary
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
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 25.1 percentage of overall work productivity | Standard Deviation 26.42 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 20.2 percentage of overall work productivity | Standard Deviation 22.36 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 17.2 percentage of overall work productivity | Standard Deviation 21.61 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 18.8 percentage of overall work productivity | Standard Deviation 22.09 |
| Filgotinib 200 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 32.8 percentage of overall work productivity | Standard Deviation 25.79 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 26.7 percentage of overall work productivity | Standard Deviation 28.11 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 20.9 percentage of overall work productivity | Standard Deviation 23.34 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 22.4 percentage of overall work productivity | Standard Deviation 22.92 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 22.9 percentage of overall work productivity | Standard Deviation 25.21 |
| Filgotinib 100 mg + MTX | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 32.3 percentage of overall work productivity | Standard Deviation 29.18 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 31.4 percentage of overall work productivity | Standard Deviation 28.43 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 21.2 percentage of overall work productivity | Standard Deviation 27.26 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 37.0 percentage of overall work productivity | Standard Deviation 25.87 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 29.3 percentage of overall work productivity | Standard Deviation 28.98 |
| Filgotinib 200 mg Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 24.5 percentage of overall work productivity | Standard Deviation 28.11 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 52 | 20.7 percentage of overall work productivity | Standard Deviation 18.67 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 4 | 48.6 percentage of overall work productivity | Standard Deviation 27.4 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 36 | 25.0 percentage of overall work productivity | Standard Deviation 25.89 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 12 | 35.5 percentage of overall work productivity | Standard Deviation 26.13 |
| MTX Monotherapy | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 | Week 24 | 26.2 percentage of overall work productivity | Standard Deviation 23.45 |