Rheumatoid Arthritis
Conditions
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
Interventions
DRUGFilgotinib
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
DRUGcsDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
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 for RA), 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 screening and Day 1 * Ongoing treatment with a stable prescription of 1 or 2 csDMARDs * Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance Key
Exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor NOTE: Other protocol 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 12 | Week 12 | 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)] ≤ 3.2 at Week 12 | Week 12 | 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 hsCRP (CRP=hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline; Week 12 | 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. |
| Percentage of Participants Who Achieved 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 hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline; Week 12 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | 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 4, 12, and 24 | Weeks 4, 12, and 24 | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Weeks 4, and 24 | 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. |
| Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | 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 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s (presence of a joint swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | 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 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 3 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | 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: HAQ-DI at Weeks 4, and 24 | Baseline; Weeks 4, and 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 (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. |
| Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | — |
| Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Weeks 4, 12, and 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 (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 4, 12, and 24 | Baseline; Weeks 4, 12, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. |
| Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Weeks 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Weeks 4, and 12 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement. |
| Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | 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 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement. |
| SF-36 PCS Score at Weeks 4, 12, and 24 | Weeks 4, 12, and 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. |
| Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline; Weeks 4, and 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. |
| SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Weeks 4, 12, and 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. |
| Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 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. |
| FACIT-Fatigue Score at Weeks 4, 12, and 24 | Weeks 4, 12, and 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 0 to 52. |
| Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline; Weeks 4, and 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 0 to 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, and 24 | Weeks 4, 12, and 24 | 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, and 24 | Weeks 4, 12, and 24 | 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, and 24 | Baseline; Weeks 4, 12, and 24 | 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, and 24 | Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. |
| WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. |
| WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline; Week 12 | 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, and 24 | Baseline; Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline; Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. |
Countries
Argentina, Australia, Belgium, France, Germany, Hungary, Israel, Japan, Mexico, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Australia, Asia, Europe, North America, and South America. The first participant was screened on 27 July 2016. The last study visit occurred on 26 June 2018.
Pre-assignment details
688 participants were screened. The enrolled participants continued to receive ongoing therapy with permitted protocol specified Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) (ie, methotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide). MTX was not permitted to be used in combination with leflunomide.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib 200 mg Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks. | 147 |
| Filgotinib 100 mg Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks. | 153 |
| Placebo Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks. | 148 |
| Total | 448 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 5 | 3 |
| Overall Study | Investigator's Discretion | 3 | 5 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Non-compliance With Study Drug | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 3 |
| Overall Study | Randomized but not Dosed | 1 | 0 | 0 |
| Overall Study | Withdrew Consent | 4 | 11 | 20 |
Baseline characteristics
| Characteristic | Filgotinib 100 mg | Filgotinib 200 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 12 | 56.0 years STANDARD_DEVIATION 12.5 | 56.0 years STANDARD_DEVIATION 12.1 | 56.0 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 40 Participants | 26 Participants | 41 Participants | 107 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 112 Participants | 120 Participants | 107 Participants | 339 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 9 Participants | 7 Participants | 10 Participants | 26 Participants |
| Race/Ethnicity, Customized Race Asian: Chinese/Taiwanese/Hong Kong Chinese | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian: Japanese | 15 Participants | 12 Participants | 13 Participants | 40 Participants |
| Race/Ethnicity, Customized Race Asian: Korean | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Asian: Other | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Asian: Vietnamese | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 12 Participants | 14 Participants | 21 Participants | 47 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 109 Participants | 110 Participants | 97 Participants | 316 Participants |
| Region of Enrollment Argentina | 3 Participants | 4 Participants | 5 Participants | 12 Participants |
| Region of Enrollment Australia | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Belgium | 3 Participants | 4 Participants | 6 Participants | 13 Participants |
| Region of Enrollment France | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
| Region of Enrollment Germany | 4 Participants | 8 Participants | 3 Participants | 15 Participants |
| Region of Enrollment Hungary | 7 Participants | 5 Participants | 4 Participants | 16 Participants |
| Region of Enrollment Israel | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Japan | 15 Participants | 12 Participants | 13 Participants | 40 Participants |
| Region of Enrollment Mexico | 13 Participants | 8 Participants | 9 Participants | 30 Participants |
| Region of Enrollment Poland | 5 Participants | 7 Participants | 7 Participants | 19 Participants |
| Region of Enrollment South Korea | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Spain | 7 Participants | 4 Participants | 5 Participants | 16 Participants |
| Region of Enrollment Switzerland | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United Kingdom | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Region of Enrollment United States | 84 Participants | 87 Participants | 84 Participants | 255 Participants |
| Sex: Female, Male Female | 119 Participants | 120 Participants | 121 Participants | 360 Participants |
| Sex: Female, Male Male | 34 Participants | 27 Participants | 27 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 153 | 0 / 148 |
| other Total, other adverse events | 39 / 147 | 35 / 153 | 31 / 148 |
| serious Total, serious adverse events | 6 / 147 | 8 / 153 | 5 / 148 |
Outcome results
Primary
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
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 12
Population: The Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 66.0 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 57.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 31.1 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [23.5, 46.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [15, 37.9]Regression, Logistic
Secondary
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 12 | 43.4 percent improvement | Standard Deviation 29.26 |
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 4 | 26.9 percent improvement | Standard Deviation 24.58 |
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 24 | 53.5 percent improvement | Standard Deviation 27.52 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 12 | 37.1 percent improvement | Standard Deviation 30.29 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 4 | 25.8 percent improvement | Standard Deviation 27.09 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 24 | 45.5 percent improvement | Standard Deviation 32.16 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 4 | 13.7 percent improvement | Standard Deviation 19.42 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 24 | 31.9 percent improvement | Standard Deviation 29.52 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 | Week 12 | 19.7 percent improvement | Standard Deviation 25.44 |
Secondary
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 7.6 score on a scale | Standard Deviation 7.68 |
| Filgotinib 200 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 30.4 score on a scale | Standard Deviation 7.75 |
| Filgotinib 100 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 6.8 score on a scale | Standard Deviation 8.22 |
| Filgotinib 100 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 31.7 score on a scale | Standard Deviation 7.76 |
| Placebo | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 31.1 score on a scale | Standard Deviation 8.17 |
| Placebo | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 3.6 score on a scale | Standard Deviation 8.16 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.5, 6.1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.6, 5.2]MMRM
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Baseline | 41.7 score on a scale | Standard Deviation 14.23 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -26.2 score on a scale | Standard Deviation 15.04 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -30.9 score on a scale | Standard Deviation 13.77 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -19.1 score on a scale | Standard Deviation 13.06 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Baseline | 40.4 score on a scale | Standard Deviation 13.23 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -16.8 score on a scale | Standard Deviation 12.95 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -23.8 score on a scale | Standard Deviation 14.33 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -27.8 score on a scale | Standard Deviation 13.54 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -17.3 score on a scale | Standard Deviation 15.22 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Baseline | 41.4 score on a scale | Standard Deviation 12 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -12.8 score on a scale | Standard Deviation 13.71 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -25.4 score on a scale | Standard Deviation 14.4 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -4.2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.9, -2.2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12.6, -6.5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10.6, -4.5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.9, -5.5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [-8.2, -1.6]MMRM
Secondary
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -2.4 score on a scale | Standard Deviation 1.32 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -2.9 score on a scale | Standard Deviation 1.29 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Baseline | 5.9 score on a scale | Standard Deviation 1.03 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -1.7 score on a scale | Standard Deviation 1.16 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -2.3 score on a scale | Standard Deviation 1.38 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -1.5 score on a scale | Standard Deviation 1.14 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -2.6 score on a scale | Standard Deviation 1.32 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Baseline | 5.9 score on a scale | Standard Deviation 0.98 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -2.1 score on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Baseline | 5.9 score on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -0.9 score on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -1.3 score on a scale | Standard Deviation 1.33 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.1, -0.6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.5, -0.9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.3, -0.7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.5, -0.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.1, -0.4]MMRM
Secondary
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 17.0 score on a scale | Standard Deviation 30.9 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 22.0 score on a scale | Standard Deviation 30.8 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 49.0 score on a scale | Standard Deviation 24.7 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 10.0 score on a scale | Standard Deviation 27.6 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 19.0 score on a scale | Standard Deviation 26.4 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 14.0 score on a scale | Standard Deviation 26.8 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 25.0 score on a scale | Standard Deviation 26.7 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 46.0 score on a scale | Standard Deviation 24 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 17.0 score on a scale | Standard Deviation 25.4 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 46.0 score on a scale | Standard Deviation 22.4 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 6.0 score on a scale | Standard Deviation 26 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 12.0 score on a scale | Standard Deviation 26.5 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00995% CI: [2, 11]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [3, 12]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [3, 13]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [2, 12]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [3, 15]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00795% CI: [2, 14]MMRM
Secondary
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline; Weeks 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 11.6 score on a scale | Standard Deviation 11.67 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 6.2 score on a scale | Standard Deviation 10.2 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 24.2 score on a scale | Standard Deviation 11.47 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 9.8 score on a scale | Standard Deviation 10.39 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 23.7 score on a scale | Standard Deviation 12.3 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 6.4 score on a scale | Standard Deviation 9.87 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 2.2 score on a scale | Standard Deviation 8.92 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 7.0 score on a scale | Standard Deviation 10.23 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 25.4 score on a scale | Standard Deviation 10.89 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.6, 5.7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [1.2, 5.4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.1, 7.1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1195% CI: [-0.5, 4.7]MMRM
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 24.2 score on a scale | Standard Deviation 11.47 |
| Filgotinib 200 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 9.6 score on a scale | Standard Deviation 11.24 |
| Filgotinib 100 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 23.7 score on a scale | Standard Deviation 12.3 |
| Filgotinib 100 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 8.3 score on a scale | Standard Deviation 10.8 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 25.4 score on a scale | Standard Deviation 10.89 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 4.5 score on a scale | Standard Deviation 10.37 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.6, 7.3]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00795% CI: [0.9, 5.5]MMRM
Secondary
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 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 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 4 | -0.39 score on a scale | Standard Deviation 0.493 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Baseline | 1.70 score on a scale | Standard Deviation 0.656 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 24 | -0.75 score on a scale | Standard Deviation 0.62 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 4 | -0.32 score on a scale | Standard Deviation 0.539 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Baseline | 1.64 score on a scale | Standard Deviation 0.683 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 24 | -0.60 score on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Baseline | 1.65 score on a scale | Standard Deviation 0.633 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 24 | -0.42 score on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 | Change from Baseline at Week 4 | -0.18 score on a scale | Standard Deviation 0.444 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.33, -0.11]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [-0.26, -0.04]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.51, -0.21]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [-0.37, -0.08]MMRM
Secondary
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -11.86 mg/L | Standard Deviation 19.76 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -9.55 mg/L | Standard Deviation 18.421 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Baseline | 17.21 mg/L | Standard Deviation 18.275 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -10.87 mg/L | Standard Deviation 19.083 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -12.02 mg/L | Standard Deviation 26.226 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Baseline | 21.49 mg/L | Standard Deviation 28.206 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -12.15 mg/L | Standard Deviation 25.502 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -11.12 mg/L | Standard Deviation 27.766 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Baseline | 16.42 mg/L | Standard Deviation 18.321 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 0.57 mg/L | Standard Deviation 15.178 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -1.50 mg/L | Standard Deviation 15.889 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 1.04 mg/L | Standard Deviation 13.942 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13.61, -7.41]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12.02, -5.82]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-14.19, -7.69]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12.22, -5.73]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13.73, -6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10.8, -2.98]MMRM
Secondary
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 3 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Baseline | 69.0 score on a scale | Standard Deviation 17.6 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -32.0 score on a scale | Standard Deviation 25.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -45.0 score on a scale | Standard Deviation 25.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -53.0 score on a scale | Standard Deviation 22.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -45.0 score on a scale | Standard Deviation 23.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Baseline | 68.0 score on a scale | Standard Deviation 18.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -41.0 score on a scale | Standard Deviation 26.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -30.0 score on a scale | Standard Deviation 24.3 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -41.0 score on a scale | Standard Deviation 23.5 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -19.0 score on a scale | Standard Deviation 22.2 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -28.0 score on a scale | Standard Deviation 26.9 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 | Baseline | 66.0 score on a scale | Standard Deviation 16.7 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-17, -7]Mixed effects model for repeated measure
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-22, -11]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-18, -7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-18, -8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.05295% CI: [-11, 0]MMRM
Secondary
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Baseline | 68.0 score on a scale | Standard Deviation 20.6 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -21.0 score on a scale | Standard Deviation 23.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -31.0 score on a scale | Standard Deviation 25.9 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -38.0 score on a scale | Standard Deviation 26.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -34.0 score on a scale | Standard Deviation 28.1 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Baseline | 69.0 score on a scale | Standard Deviation 20.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -27.0 score on a scale | Standard Deviation 28.4 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -20.0 score on a scale | Standard Deviation 26.1 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -24.0 score on a scale | Standard Deviation 28 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -10.0 score on a scale | Standard Deviation 22.6 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -14.0 score on a scale | Standard Deviation 26.3 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 | Baseline | 70.0 score on a scale | Standard Deviation 18 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-17, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-16, -5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-24, -12]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-19, -7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-25, -12]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-19, -6]MMRM
Secondary
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -30.0 score on a scale | Standard Deviation 27.9 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -37.0 score on a scale | Standard Deviation 28.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Baseline | 66.0 score on a scale | Standard Deviation 21.6 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -22.0 score on a scale | Standard Deviation 24.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -27.0 score on a scale | Standard Deviation 30.9 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -20.0 score on a scale | Standard Deviation 26.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -35.0 score on a scale | Standard Deviation 29.1 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Baseline | 67.0 score on a scale | Standard Deviation 21.7 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -24.0 score on a scale | Standard Deviation 28.3 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Baseline | 68.0 score on a scale | Standard Deviation 19.9 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -8.0 score on a scale | Standard Deviation 22.6 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -14.0 score on a scale | Standard Deviation 27 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-21, -10]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-19, -8]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-23, -11]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-19, -7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-23, -10]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-19, -5]MMRM
Secondary
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s (presence of a joint swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -12.0 swollen joint count | Standard Deviation 10.5 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -14.0 swollen joint count | Standard Deviation 10.3 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -10.0 swollen joint count | Standard Deviation 10.6 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Baseline | 18.0 swollen joint count | Standard Deviation 12.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -10.0 swollen joint count | Standard Deviation 8.6 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -7.0 swollen joint count | Standard Deviation 9.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -13.0 swollen joint count | Standard Deviation 10 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Baseline | 17.0 swollen joint count | Standard Deviation 12.4 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -12.0 swollen joint count | Standard Deviation 8.7 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Baseline | 17.0 swollen joint count | Standard Deviation 9.7 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -7.0 swollen joint count | Standard Deviation 8.8 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -8.0 swollen joint count | Standard Deviation 8.9 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00895% CI: [-5, -1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.6595% CI: [-2, 1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00895% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03995% CI: [-4, 0]MMRM
Secondary
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -22.0 tender joint count | Standard Deviation 14.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Baseline | 28.0 tender joint count | Standard Deviation 16.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -18.0 tender joint count | Standard Deviation 14.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -13.0 tender joint count | Standard Deviation 13.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -16.0 tender joint count | Standard Deviation 11.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -19.0 tender joint count | Standard Deviation 13 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -11.0 tender joint count | Standard Deviation 11 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Baseline | 26.0 tender joint count | Standard Deviation 15.4 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -17.0 tender joint count | Standard Deviation 13.3 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -8.0 tender joint count | Standard Deviation 13.8 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -12.0 tender joint count | Standard Deviation 13.4 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 | Baseline | 27.0 tender joint count | Standard Deviation 15.5 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [-7, -1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.02795% CI: [-6, 0]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8, -3]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -4]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [-7, -1]MMRM
Secondary
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 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; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 44.5 score on a scale | Standard Deviation 11.97 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 3.5 score on a scale | Standard Deviation 9.17 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 5.3 score on a scale | Standard Deviation 10.6 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 6.5 score on a scale | Standard Deviation 12.5 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 4.6 score on a scale | Standard Deviation 9.22 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 44.2 score on a scale | Standard Deviation 11.59 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 4.6 score on a scale | Standard Deviation 9.76 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 3.0 score on a scale | Standard Deviation 9.03 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 4.3 score on a scale | Standard Deviation 9.44 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 1.2 score on a scale | Standard Deviation 9.34 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 3.7 score on a scale | Standard Deviation 9.17 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 44.3 score on a scale | Standard Deviation 11.32 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.01995% CI: [0.4, 4.2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.07395% CI: [-0.2, 3.6]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04595% CI: [0, 4.1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.3295% CI: [-1, 3]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1295% CI: [-0.5, 4.2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.9695% CI: [-2.3, 2.4]MMRM
Secondary
Change From Baseline in SF-36 PCS Score at Weeks 4, and 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; Weeks 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 9.4 score on a scale | Standard Deviation 8.23 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 5.1 score on a scale | Standard Deviation 6.34 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 30.4 score on a scale | Standard Deviation 7.75 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 4.5 score on a scale | Standard Deviation 6.53 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 31.7 score on a scale | Standard Deviation 7.76 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 9.0 score on a scale | Standard Deviation 8.44 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 31.1 score on a scale | Standard Deviation 8.17 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 6.6 score on a scale | Standard Deviation 7.95 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 2.5 score on a scale | Standard Deviation 5.91 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.1, 3.9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00595% CI: [0.6, 3.4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.9, 5.9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [1.1, 5.2]MMRM
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Baseline | 43.4 score on a scale | Standard Deviation 14.64 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -20.1 score on a scale | Standard Deviation 13.73 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -27.6 score on a scale | Standard Deviation 15.54 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -32.1 score on a scale | Standard Deviation 14.41 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -28.8 score on a scale | Standard Deviation 14.19 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Baseline | 42.6 score on a scale | Standard Deviation 14.16 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -24.9 score on a scale | Standard Deviation 15.01 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -18.1 score on a scale | Standard Deviation 13.19 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -24.9 score on a scale | Standard Deviation 14.84 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -12.9 score on a scale | Standard Deviation 14.01 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -17.2 score on a scale | Standard Deviation 15.52 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 | Baseline | 43.0 score on a scale | Standard Deviation 12.33 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.1, -5.1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.9, -2.9]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13.8, -7.5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.8, -5.5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13.5, -6.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.4, -2.7]MMRM
Secondary
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
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 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.70 score on a scale | Standard Deviation 0.656 |
| Filgotinib 200 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.55 score on a scale | Standard Deviation 0.59 |
| Filgotinib 100 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.64 score on a scale | Standard Deviation 0.683 |
| Filgotinib 100 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.48 score on a scale | Standard Deviation 0.602 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.23 score on a scale | Standard Deviation 0.547 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.65 score on a scale | Standard Deviation 0.633 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (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: [-0.45, -0.19]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.4, -0.14]MMRM
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 65.6 percentage of activity impairment | Standard Deviation 22.16 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -16.0 percentage of activity impairment | Standard Deviation 24.64 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -25.0 percentage of activity impairment | Standard Deviation 26.81 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -32.5 percentage of activity impairment | Standard Deviation 27.37 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -27.1 percentage of activity impairment | Standard Deviation 27.97 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 64.6 percentage of activity impairment | Standard Deviation 23.07 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -19.2 percentage of activity impairment | Standard Deviation 28.32 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -14.3 percentage of activity impairment | Standard Deviation 22.89 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -18.4 percentage of activity impairment | Standard Deviation 31.23 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -4.7 percentage of activity impairment | Standard Deviation 25.06 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -11.3 percentage of activity impairment | Standard Deviation 25.75 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 65.4 percentage of activity impairment | Standard Deviation 23.33 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 46.9 percentage of impairment while working | Standard Deviation 24.71 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -19.1 percentage of impairment while working | Standard Deviation 25.63 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -20.0 percentage of impairment while working | Standard Deviation 25.56 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -18.6 percentage of impairment while working | Standard Deviation 22.48 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -28.7 percentage of impairment while working | Standard Deviation 25.26 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 51.0 percentage of impairment while working | Standard Deviation 27.95 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -18.8 percentage of impairment while working | Standard Deviation 28.64 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -13.1 percentage of impairment while working | Standard Deviation 25.75 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -20.0 percentage of impairment while working | Standard Deviation 31.36 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -5.3 percentage of impairment while working | Standard Deviation 25.52 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -10.8 percentage of impairment while working | Standard Deviation 20.32 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 55.7 percentage of impairment while working | Standard Deviation 26.64 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 52.0 percentage of overall work productivity | Standard Deviation 24.02 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -20.9 percentage of overall work productivity | Standard Deviation 28.94 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -22.8 percentage of overall work productivity | Standard Deviation 29.2 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -20.5 percentage of overall work productivity | Standard Deviation 26.2 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -26.4 percentage of overall work productivity | Standard Deviation 29.87 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 55.8 percentage of overall work productivity | Standard Deviation 30.53 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -19.5 percentage of overall work productivity | Standard Deviation 31.49 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -12.3 percentage of overall work productivity | Standard Deviation 28.05 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -16.7 percentage of overall work productivity | Standard Deviation 33.28 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -3.4 percentage of overall work productivity | Standard Deviation 25.48 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -8.3 percentage of overall work productivity | Standard Deviation 20.16 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 56.7 percentage of overall work productivity | Standard Deviation 27.6 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 11.3 percentage of work time missed | Standard Deviation 16.31 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -4.3 percentage of work time missed | Standard Deviation 20.98 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -3.6 percentage of work time missed | Standard Deviation 17.6 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -4.6 percentage of work time missed | Standard Deviation 22.5 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -3.1 percentage of work time missed | Standard Deviation 34.28 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 19.2 percentage of work time missed | Standard Deviation 28.57 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -7.0 percentage of work time missed | Standard Deviation 30.93 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -3.4 percentage of work time missed | Standard Deviation 24.57 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 3.7 percentage of work time missed | Standard Deviation 25.13 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 4.0 percentage of work time missed | Standard Deviation 20.75 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 3.8 percentage of work time missed | Standard Deviation 18.4 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 10.8 percentage of work time missed | Standard Deviation 25.65 |
Secondary
EQ-5D Current Health VAS at Weeks 4, 12, and 24
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 66.0 score on a scale | Standard Deviation 23.2 |
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 59.0 score on a scale | Standard Deviation 22.1 |
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 70.0 score on a scale | Standard Deviation 21.8 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 65.0 score on a scale | Standard Deviation 22.2 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 60.0 score on a scale | Standard Deviation 19.8 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 69.0 score on a scale | Standard Deviation 21.3 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 52.0 score on a scale | Standard Deviation 24.2 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 62.0 score on a scale | Standard Deviation 23 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 58.0 score on a scale | Standard Deviation 23 |
Secondary
FACIT-Fatigue Score at Weeks 4, 12, and 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 0 to 52.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 36.3 score on a scale | Standard Deviation 11.58 |
| Filgotinib 200 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 30.4 score on a scale | Standard Deviation 12.48 |
| Filgotinib 200 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 34.0 score on a scale | Standard Deviation 12.08 |
| Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 30.3 score on a scale | Standard Deviation 12.3 |
| Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 32.1 score on a scale | Standard Deviation 13.66 |
| Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 34.4 score on a scale | Standard Deviation 12.51 |
| Placebo | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 33.3 score on a scale | Standard Deviation 11.26 |
| Placebo | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 30.4 score on a scale | Standard Deviation 11.79 |
| Placebo | FACIT-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 27.9 score on a scale | Standard Deviation 11.29 |
Secondary
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 18 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 24 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 68 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 45 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 70 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 23 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 67 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 33 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 45 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 16 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 34 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Severe Problems | 11 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 38 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Moderate Problems | 23 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 51 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Slight Problems | 38 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 34 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 17 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | No Problems | 51 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 13 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 15 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 25 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 19 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 55 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 47 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 15 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 18 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 25 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 61 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 45 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 54 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 31 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 27 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 47 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 12 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 65 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 69 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 26 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 78 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 19 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 13 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 33 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 83 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 25 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 58 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 6 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 16 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 38 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 79 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 79 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 33 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 21 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 23 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 6 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 31 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 41 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 11 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 16 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 56 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 56 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 14 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 20 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 42 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 36 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 10 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 77 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 41 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 21 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 84 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 30 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 26 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 3 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 62 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 30 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 13 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 45 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 49 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 33 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 16 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 57 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 48 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 29 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 9 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | No Problems | 38 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Slight Problems | 45 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Moderate Problems | 18 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 67 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 43 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 27 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 6 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 78 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 46 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 15 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 58 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 16 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 38 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 50 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 38 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 12 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 6 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 51 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 37 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 3 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 41 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 32 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 28 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 7 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 11 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 57 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 50 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 22 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 4 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 71 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 36 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 56 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 44 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 5 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 41 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 21 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 34 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 10 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 11 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 11 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 43 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 24 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 45 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 31 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 60 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 6 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 10 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 62 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 4 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 22 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 4 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 49 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 25 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 14 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 49 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 4 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 33 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 3 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 38 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 26 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 46 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 25 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 32 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 29 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 36 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 48 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 19 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 49 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 32 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 10 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | No Problems | 32 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 44 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Slight Problems | 29 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 6 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 38 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Moderate Problems | 24 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 15 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Severe Problems | 5 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 19 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 20 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 24 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 50 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 28 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 36 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 52 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 3 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 57 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 28 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 23 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 37 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 34 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 20 Participants |
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Good Response | 58 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | No Response | 8 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | No Response | 13 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Moderate Response | 65 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Good Response | 32 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Moderate Response | 43 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | No Response | 38 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Moderate Response | 74 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Good Response | 70 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Moderate Response | 58 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Good Response | 34 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Moderate Response | 65 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | No Response | 46 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Good Response | 56 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | No Response | 23 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Good Response | 58 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Moderate Response | 47 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | No Response | 6 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | No Response | 63 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Good Response | 13 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Good Response | 31 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 4 | Moderate Response | 53 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | No Response | 12 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Moderate Response | 51 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | Good Response | 23 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 24 | Moderate Response | 45 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 | Week 12 | No Response | 54 Participants |
Secondary
Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
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 4, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 4 | 51.7 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 24 | 69.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 4 | 44.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 24 | 54.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 4 | 25.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 | Week 24 | 34.5 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [14.6, 37.4]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: <0.00195% CI: [7.5, 30]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [23.6, 46.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: <0.00195% CI: [8.8, 32.1]Regression, Logistic
Secondary
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 24 | 45.6 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 4 | 22.4 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 12 | 42.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 24 | 35.3 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 4 | 21.6 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 12 | 32.0 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 24 | 18.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 12 | 14.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 | Week 4 | 7.4 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [6.4, 23.7]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: <0.00195% CI: [5.7, 22.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [17.5, 38.5]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [7.1, 27.2]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [15.8, 37.6]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: 0.00295% CI: [5.9, 26.9]Regression, Logistic
Secondary
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
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 4, 12, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 12 | 21.8 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 4 | 6.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 24 | 32.0 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 12 | 14.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 4 | 8.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 24 | 20.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 4 | 2.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 24 | 8.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 | Week 12 | 6.8 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: 0.1695% CI: [-1.9, 8.8]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: 0.03995% CI: [0, 11.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [6.5, 23.5]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: 0.03695% CI: [0.1, 15.2]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [14.5, 33.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: 0.00495% CI: [3.7, 20.6]Regression, Logistic
Secondary
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 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 (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 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 12 | 66.7 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 4 | 60.4 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 24 | 68.8 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 12 | 66.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 4 | 54.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 24 | 54.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 4 | 40.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 24 | 35.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 | Week 12 | 44.4 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4.p-value: <0.00195% CI: [8.1, 32.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4.p-value: 0.01395% CI: [2.4, 26.5]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12.p-value: <0.00195% CI: [10.3, 34.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12.p-value: <0.00195% CI: [10, 33.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24.p-value: <0.00195% CI: [21.8, 44.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24.p-value: 0.00195% CI: [6.8, 30.5]Regression, Logistic
Secondary
Percentage of Participants Who Achieved 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 hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Week 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24 | 30.6 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24 | 26.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24 | 12.2 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [8.6, 28.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: 0.00395% CI: [4.6, 23.4]Regression, Logistic
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 4, and 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 4 | 10.2 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 12 | 22.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 12 | 25.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 4 | 11.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 4 | 2.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 | Week 12 | 8.1 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4.p-value: 0.01295% CI: [1.3, 13.7]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4.p-value: 0.00695% CI: [2.7, 15.5]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12.p-value: <0.00195% CI: [5.6, 23.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12.p-value: <0.00195% CI: [8.5, 26.2]Regression, Logistic
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 4, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 4 | 21.8 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 24 | 48.3 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 4 | 22.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 24 | 37.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 4 | 9.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 | Week 24 | 20.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 4.p-value: 0.00495% CI: [3.5, 21.2]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4.p-value: 0.00395% CI: [4, 21.5]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24.p-value: <0.00195% CI: [16.3, 38.4]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24.p-value: 0.00195% CI: [6.2, 27.7]Regression, Logistic
Secondary
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12
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 hsCRP (CRP=hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12 | 40.8 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12 | 37.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12 | 15.5 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [14.7, 35.8]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [11.4, 32]Regression, Logistic
Secondary
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 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.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 50.6 score on a scale | Standard Deviation 10.35 |
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 50.2 score on a scale | Standard Deviation 10.58 |
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 48.0 score on a scale | Standard Deviation 11.48 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 49.5 score on a scale | Standard Deviation 10.72 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 47.3 score on a scale | Standard Deviation 11.51 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 48.8 score on a scale | Standard Deviation 11.02 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 49.1 score on a scale | Standard Deviation 10.56 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 47.9 score on a scale | Standard Deviation 11.01 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 45.5 score on a scale | Standard Deviation 11.11 |
Secondary
SF-36 PCS Score at Weeks 4, 12, and 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.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 4 | 35.4 score on a scale | Standard Deviation 8.72 |
| Filgotinib 200 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 24 | 40.4 score on a scale | Standard Deviation 9.64 |
| Filgotinib 200 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 12 | 38.3 score on a scale | Standard Deviation 10.14 |
| Filgotinib 100 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 12 | 38.6 score on a scale | Standard Deviation 9.39 |
| Filgotinib 100 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 4 | 36.4 score on a scale | Standard Deviation 9.29 |
| Filgotinib 100 mg | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 24 | 40.3 score on a scale | Standard Deviation 10.31 |
| Placebo | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 24 | 37.7 score on a scale | Standard Deviation 9.09 |
| Placebo | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 4 | 33.7 score on a scale | Standard Deviation 8.67 |
| Placebo | SF-36 PCS Score at Weeks 4, 12, and 24 | Week 12 | 35.1 score on a scale | Standard Deviation 9.9 |
Secondary
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 5.6 percentage of work time missed | Standard Deviation 13.79 |
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 8.8 percentage of work time missed | Standard Deviation 21.01 |
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 7.6 percentage of work time missed | Standard Deviation 16.37 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 14.6 percentage of work time missed | Standard Deviation 27.13 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 18.2 percentage of work time missed | Standard Deviation 30.93 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 13.8 percentage of work time missed | Standard Deviation 26.23 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 14.3 percentage of work time missed | Standard Deviation 27.52 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 8.5 percentage of work time missed | Standard Deviation 18.08 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 12.1 percentage of work time missed | Standard Deviation 24.39 |
Secondary
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 40.3 percentage of activity impairment | Standard Deviation 26.75 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 49.6 percentage of activity impairment | Standard Deviation 26.56 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 33.3 percentage of activity impairment | Standard Deviation 24.61 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 45.5 percentage of activity impairment | Standard Deviation 28.23 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 49.9 percentage of activity impairment | Standard Deviation 27.43 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 37.5 percentage of activity impairment | Standard Deviation 27 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 60.3 percentage of activity impairment | Standard Deviation 25.49 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 45.7 percentage of activity impairment | Standard Deviation 25.57 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 53.0 percentage of activity impairment | Standard Deviation 27.26 |
Secondary
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 23.9 percentage of impairment while working | Standard Deviation 20.99 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 27.4 percentage of impairment while working | Standard Deviation 22.5 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 28.0 percentage of impairment while working | Standard Deviation 27.57 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 34.8 percentage of impairment while working | Standard Deviation 27.22 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 37.8 percentage of impairment while working | Standard Deviation 25.43 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 25.6 percentage of impairment while working | Standard Deviation 22.1 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 48.6 percentage of impairment while working | Standard Deviation 29.81 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 36.7 percentage of impairment while working | Standard Deviation 26.95 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 44.2 percentage of impairment while working | Standard Deviation 29.21 |
Secondary
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 26.9 percentage of overall work productivity | Standard Deviation 24.2 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 30.8 percentage of overall work productivity | Standard Deviation 24.36 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 31.7 percentage of overall work productivity | Standard Deviation 29.94 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 39.5 percentage of overall work productivity | Standard Deviation 29.37 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 43.1 percentage of overall work productivity | Standard Deviation 27.82 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 31.4 percentage of overall work productivity | Standard Deviation 25.65 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 51.3 percentage of overall work productivity | Standard Deviation 30.85 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 39.8 percentage of overall work productivity | Standard Deviation 29.49 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 46.9 percentage of overall work productivity | Standard Deviation 30.63 |