FINCH 2: Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02873936
Collaborator
Galapagos NV (Industry)
449
104
3
23
4.3
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
449 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
Actual Study Start Date
:
Jul 27, 2016
Actual Primary Completion Date
:
Mar 20, 2018
Actual Study Completion Date
:
Jun 26, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Filgotinib 200 mg Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s) |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Drug: csDMARDs
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)
|
| Experimental: Filgotinib 100 mg Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s) |
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Drug: csDMARDs
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)
|
| Placebo Comparator: Placebo Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s) |
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Drug: csDMARDs
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)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria 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/ Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsville | Alabama | United States | ||
| 2 | Gilbert | Arizona | United States | ||
| 3 | Covina | California | United States | ||
| 4 | Hemet | California | United States | ||
| 5 | La Jolla | California | United States | ||
| 6 | Palm Desert | California | United States | ||
| 7 | Palo Alto | California | United States | ||
| 8 | Riverside | California | United States | ||
| 9 | Upland | California | United States | ||
| 10 | Victorville | California | United States | ||
| 11 | Whittier | California | United States | ||
| 12 | Aventura | Florida | United States | ||
| 13 | DeBary | Florida | United States | ||
| 14 | Jacksonville | Florida | United States | ||
| 15 | Miami | Florida | United States | ||
| 16 | Orlando | Florida | United States | ||
| 17 | Plantation | Florida | United States | ||
| 18 | Port Richey | Florida | United States | ||
| 19 | Decatur | Georgia | United States | ||
| 20 | Kansas City | Kansas | United States | ||
| 21 | Wichita | Kansas | United States | ||
| 22 | Elizabethtown | Kentucky | United States | ||
| 23 | Lexington | Kentucky | United States | ||
| 24 | Cumberland | Maryland | United States | ||
| 25 | Frederick | Maryland | United States | ||
| 26 | Worcester | Massachusetts | United States | ||
| 27 | Detroit | Michigan | United States | ||
| 28 | Saint Clair Shores | Michigan | United States | ||
| 29 | Hattiesburg | Mississippi | United States | ||
| 30 | Tupelo | Mississippi | United States | ||
| 31 | Saint Louis | Missouri | United States | ||
| 32 | Lincoln | Nebraska | United States | ||
| 33 | Lebanon | New Hampshire | United States | ||
| 34 | Freehold | New Jersey | United States | ||
| 35 | Toms River | New Jersey | United States | ||
| 36 | Brooklyn | New York | United States | ||
| 37 | Charlotte | North Carolina | United States | ||
| 38 | Greenville | North Carolina | United States | ||
| 39 | Salisbury | North Carolina | United States | ||
| 40 | Middleburg Heights | Ohio | United States | ||
| 41 | Oklahoma City | Oklahoma | United States | ||
| 42 | Tulsa | Oklahoma | United States | ||
| 43 | Philadelphia | Pennsylvania | United States | ||
| 44 | Wyomissing | Pennsylvania | United States | ||
| 45 | Charleston | South Carolina | United States | ||
| 46 | Columbia | South Carolina | United States | ||
| 47 | Myrtle Beach | South Carolina | United States | ||
| 48 | Orangeburg | South Carolina | United States | ||
| 49 | Memphis | Tennessee | United States | ||
| 50 | Beaumont | Texas | United States | ||
| 51 | Corpus Christi | Texas | United States | ||
| 52 | Mesquite | Texas | United States | ||
| 53 | Plano | Texas | United States | ||
| 54 | San Antonio | Texas | United States | ||
| 55 | Webster | Texas | United States | ||
| 56 | Buenos Aires | Argentina | |||
| 57 | Caba | Argentina | |||
| 58 | San Juan | Argentina | |||
| 59 | Victoria Park | Western Australia | Australia | ||
| 60 | Gent | Belgium | |||
| 61 | Leuven | Belgium | |||
| 62 | Merksem | Belgium | |||
| 63 | Montpellier | France | |||
| 64 | Berlin | Germany | |||
| 65 | Hamburg | Germany | |||
| 66 | Ratingen | Germany | |||
| 67 | Budapest | Hungary | |||
| 68 | Gyula | Hungary | |||
| 69 | Székesfehérvár | Hungary | |||
| 70 | Haifa | Israel | |||
| 71 | Ramat Gan | Israel | |||
| 72 | Hiroshima | Japan | |||
| 73 | Izumo | Japan | |||
| 74 | Katō | Japan | |||
| 75 | Kawagoe | Japan | |||
| 76 | Kumamoto | Japan | |||
| 77 | Narashino | Japan | |||
| 78 | Okayama | Japan | |||
| 79 | Sagamihara | Japan | |||
| 80 | Sapporo | Japan | |||
| 81 | Shinjuku-Ku | Japan | |||
| 82 | Takaoka | Japan | |||
| 83 | Takasaki | Japan | |||
| 84 | Tokorozawa | Japan | |||
| 85 | Tokyo | Japan | |||
| 86 | Tomigusuku | Japan | |||
| 87 | Seoul | Korea, Republic of | |||
| 88 | Chihuahua | Mexico | |||
| 89 | Distrito Federal | Mexico | |||
| 90 | Mérida | Mexico | |||
| 91 | Białystok | Poland | |||
| 92 | Poznań | Poland | |||
| 93 | Warszawa | Poland | |||
| 94 | Wroclaw | Poland | |||
| 95 | Madrid | Spain | |||
| 96 | Málaga | Spain | |||
| 97 | Sabadell | Spain | |||
| 98 | Valencia | Spain | |||
| 99 | Sankt Gallen | Switzerland | |||
| 100 | Doncaster | United Kingdom | |||
| 101 | Edinburgh | United Kingdom | |||
| 102 | Goodmayes | United Kingdom | |||
| 103 | Harlow | United Kingdom | |||
| 104 | Newcastle upon Tyne | United Kingdom |
Sponsors and Collaborators
- Gilead Sciences
- Galapagos NV
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02873936
Other Study ID Numbers:
- GS-US-417-0302
- 2016-000569-21
First Posted:
Aug 22, 2016
Last Update Posted:
May 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 148 | 153 | 148 |
| COMPLETED | 135 | 130 | 116 |
| NOT COMPLETED | 13 | 23 | 32 |
Baseline Characteristics
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 147 | 153 | 148 | 448 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
56.0
(12.5)
|
55.0
(12.0)
|
56.0
(12.1)
|
56.0
(12.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
120
81.6%
|
119
77.8%
|
121
81.8%
|
360
80.4%
|
| Male |
27
18.4%
|
34
22.2%
|
27
18.2%
|
88
19.6%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| American Indian or Alaska Native |
7
4.8%
|
9
5.9%
|
10
6.8%
|
26
5.8%
|
| Asian: Japanese |
12
8.2%
|
15
9.8%
|
13
8.8%
|
40
8.9%
|
| Asian: Chinese/Taiwanese/Hong Kong Chinese |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian: Vietnamese |
1
0.7%
|
0
0%
|
0
0%
|
1
0.2%
|
| Asian: Korean |
2
1.4%
|
2
1.3%
|
1
0.7%
|
5
1.1%
|
| Asian: Other |
0
0%
|
3
2%
|
1
0.7%
|
4
0.9%
|
| Black or African American |
14
9.5%
|
12
7.8%
|
21
14.2%
|
47
10.5%
|
| Native Hawaiian or Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
110
74.8%
|
109
71.2%
|
97
65.5%
|
316
70.5%
|
| Other |
1
0.7%
|
3
2%
|
2
1.4%
|
6
1.3%
|
| Not Permitted |
0
0%
|
0
0%
|
3
2%
|
3
0.7%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Hispanic or Latino |
26
17.7%
|
40
26.1%
|
41
27.7%
|
107
23.9%
|
| Not Hispanic or Latino |
120
81.6%
|
112
73.2%
|
107
72.3%
|
339
75.7%
|
| Not Permitted |
1
0.7%
|
1
0.7%
|
0
0%
|
2
0.4%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
87
59.2%
|
84
54.9%
|
84
56.8%
|
255
56.9%
|
| Spain |
4
2.7%
|
7
4.6%
|
5
3.4%
|
16
3.6%
|
| Germany |
8
5.4%
|
4
2.6%
|
3
2%
|
15
3.3%
|
| Belgium |
4
2.7%
|
3
2%
|
6
4.1%
|
13
2.9%
|
| France |
2
1.4%
|
2
1.3%
|
5
3.4%
|
9
2%
|
| United Kingdom |
2
1.4%
|
5
3.3%
|
2
1.4%
|
9
2%
|
| South Korea |
2
1.4%
|
2
1.3%
|
1
0.7%
|
5
1.1%
|
| Australia |
1
0.7%
|
1
0.7%
|
2
1.4%
|
4
0.9%
|
| Israel |
0
0%
|
1
0.7%
|
2
1.4%
|
3
0.7%
|
| Switzerland |
1
0.7%
|
1
0.7%
|
0
0%
|
2
0.4%
|
| Poland |
7
4.8%
|
5
3.3%
|
7
4.7%
|
19
4.2%
|
| Hungary |
5
3.4%
|
7
4.6%
|
4
2.7%
|
16
3.6%
|
| Mexico |
8
5.4%
|
13
8.5%
|
9
6.1%
|
30
6.7%
|
| Argentina |
4
2.7%
|
3
2%
|
5
3.4%
|
12
2.7%
|
| Japan |
12
8.2%
|
15
9.8%
|
13
8.8%
|
40
8.9%
|
Outcome Measures
| Title | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 |
|---|---|
| Description | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Number (95% Confidence Interval) [percentage of participants] |
66.0
44.9%
|
57.5
37.6%
|
31.1
21%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 34.9 | |
| Confidence Interval |
(2-Sided) 95% 23.5 to 46.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 26.4 | |
| Confidence Interval |
(2-Sided) 95% 15.0 to 37.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 |
|---|---|
| Description | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
1.70
(0.656)
|
1.64
(0.683)
|
1.65
(0.633)
|
| Change from Baseline at Week 12 |
-0.55
(0.590)
|
-0.48
(0.602)
|
-0.23
(0.547)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.066 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.065 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12 |
|---|---|
| Description | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Number (95% Confidence Interval) [percentage of participants] |
40.8
27.8%
|
37.3
24.4%
|
15.5
10.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 25.3 | |
| Confidence Interval |
(2-Sided) 95% 14.7 to 35.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 21.7 | |
| Confidence Interval |
(2-Sided) 95% 11.4 to 32.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 |
|---|---|
| Description | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 153 | 148 |
| Baseline |
30.4
(7.75)
|
31.7
(7.76)
|
31.1
(8.17)
|
| Change from Baseline at Week 12 |
7.6
(7.68)
|
6.8
(8.22)
|
3.6
(8.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 4.3 | |
| Confidence Interval |
(2-Sided) 95% 2.5 to 6.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.92 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.4 | |
| Confidence Interval |
(2-Sided) 95% 1.6 to 5.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.92 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24 |
|---|---|
| Description | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Number (95% Confidence Interval) [percentage of participants] |
30.6
20.8%
|
26.1
17.1%
|
12.2
8.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 18.5 | |
| Confidence Interval |
(2-Sided) 95% 8.6 to 28.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 14.0 | |
| Confidence Interval |
(2-Sided) 95% 4.6 to 23.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 |
|---|---|
| Description | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 152 | 147 |
| Baseline |
24.2
(11.47)
|
23.7
(12.30)
|
25.4
(10.89)
|
| Change from Baseline at Week 12 |
9.6
(11.24)
|
8.3
(10.80)
|
4.5
(10.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 5.0 | |
| Confidence Interval |
(2-Sided) 95% 2.6 to 7.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.19 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.2 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 5.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.18 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 |
|---|---|
| Description | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
22.4
15.2%
|
21.6
14.1%
|
7.4
5%
|
| Week 12 |
42.9
29.2%
|
32.0
20.9%
|
14.9
10.1%
|
| Week 24 |
45.6
31%
|
35.3
23.1%
|
18.9
12.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 15.0 | |
| Confidence Interval |
(2-Sided) 95% 6.4 to 23.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 14.1 | |
| Confidence Interval |
(2-Sided) 95% 5.7 to 22.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 28.0 | |
| Confidence Interval |
(2-Sided) 95% 17.5 to 38.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 17.2 | |
| Confidence Interval |
(2-Sided) 95% 7.1 to 27.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 26.7 | |
| Confidence Interval |
(2-Sided) 95% 15.8 to 37.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 16.4 | |
| Confidence Interval |
(2-Sided) 95% 5.9 to 26.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 |
|---|---|
| Description | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
6.1
4.1%
|
8.5
5.6%
|
2.7
1.8%
|
| Week 12 |
21.8
14.8%
|
14.4
9.4%
|
6.8
4.6%
|
| Week 24 |
32.0
21.8%
|
20.3
13.3%
|
8.1
5.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 3.4 | |
| Confidence Interval |
(2-Sided) 95% -1.9 to 8.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 5.8 | |
| Confidence Interval |
(2-Sided) 95% -0.0 to 11.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 15.0 | |
| Confidence Interval |
(2-Sided) 95% 6.5 to 23.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.036 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 7.6 | |
| Confidence Interval |
(2-Sided) 95% 0.1 to 15.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 23.9 | |
| Confidence Interval |
(2-Sided) 95% 14.5 to 33.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 12.2 | |
| Confidence Interval |
(2-Sided) 95% 3.7 to 20.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 |
|---|---|
| Description | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Time Frame | Weeks 4, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
51.7
35.2%
|
44.4
29%
|
25.7
17.4%
|
| Week 24 |
69.4
47.2%
|
54.9
35.9%
|
34.5
23.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 26.0 | |
| Confidence Interval |
(2-Sided) 95% 14.6 to 37.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 18.8 | |
| Confidence Interval |
(2-Sided) 95% 7.5 to 30.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 34.9 | |
| Confidence Interval |
(2-Sided) 95% 23.6 to 46.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 20.4 | |
| Confidence Interval |
(2-Sided) 95% 8.8 to 32.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 |
|---|---|
| Description | TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 153 | 148 |
| Baseline |
28.0
(16.1)
|
26.0
(15.4)
|
27.0
(15.5)
|
| Change from Baseline at Week 4 |
-13.0
(13.5)
|
-11.0
(11.0)
|
-8.0
(13.8)
|
| Change from Baseline at Week 12 |
-18.0
(14.1)
|
-16.0
(11.8)
|
-12.0
(13.4)
|
| Change from Baseline at Week 24 |
-22.0
(14.2)
|
-19.0
(13.0)
|
-17.0
(13.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -7.0 to -1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.4 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.0 | |
| Confidence Interval |
(2-Sided) 95% -6.0 to -0.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.4 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -6.0 | |
| Confidence Interval |
(2-Sided) 95% -8.0 to -3.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.3 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -7.0 to -2.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.3 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -7.0 | |
| Confidence Interval |
(2-Sided) 95% -10.0 to -4.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.5 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -7.0 to -1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.5 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 |
|---|---|
| Description | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 153 | 148 |
| Baseline |
18.0
(12.5)
|
17.0
(12.4)
|
17.0
(9.7)
|
| Change from Baseline at Week 4 |
-10.0
(10.6)
|
-7.0
(9.2)
|
-7.0
(8.8)
|
| Change from Baseline at Week 12 |
-12.0
(10.5)
|
-10.0
(8.6)
|
-8.0
(8.9)
|
| Change from Baseline at Week 24 |
-14.0
(10.3)
|
-13.0
(10.0)
|
-12.0
(8.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -3.0 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to -1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.0 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.0 | |
| Confidence Interval |
(2-Sided) 95% -2.0 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.0 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to -2.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.9 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -4.0 to -1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.9 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.0 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to -2.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.9 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -4.0 to -0.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.9 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 |
|---|---|
| Description | SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
68.0
(20.6)
|
69.0
(20.2)
|
70.0
(18.0)
|
| Change from Baseline at Week 4 |
-21.0
(23.2)
|
-20.0
(26.1)
|
-10.0
(22.6)
|
| Change from Baseline at Week 12 |
-31.0
(25.9)
|
-27.0
(28.4)
|
-14.0
(26.3)
|
| Change from Baseline at Week 24 |
-38.0
(26.8)
|
-34.0
(28.1)
|
-24.0
(28.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.0 | |
| Confidence Interval |
(2-Sided) 95% -17.0 to -7.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -11.0 | |
| Confidence Interval |
(2-Sided) 95% -16.0 to -5.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -18.0 | |
| Confidence Interval |
(2-Sided) 95% -24.0 to -12.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.0 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13.0 | |
| Confidence Interval |
(2-Sided) 95% -19.0 to -7.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.0 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -18.0 | |
| Confidence Interval |
(2-Sided) 95% -25.0 to -12.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.4 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13.0 | |
| Confidence Interval |
(2-Sided) 95% -19.0 to -6.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.4 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
69.0
(17.6)
|
68.0
(18.7)
|
66.0
(16.7)
|
| Change from Baseline at Week 4 |
-32.0
(25.2)
|
-30.0
(24.3)
|
-19.0
(22.2)
|
| Change from Baseline at Week 12 |
-45.0
(25.2)
|
-41.0
(26.7)
|
-28.0
(26.9)
|
| Change from Baseline at Week 24 |
-53.0
(22.7)
|
-45.0
(23.8)
|
-41.0
(23.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | Mixed effects model for repeated measure | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.0 | |
| Confidence Interval |
(2-Sided) 95% -17.0 to -7.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.6 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.0 | |
| Confidence Interval |
(2-Sided) 95% -15.0 to -5.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.6 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -16.0 | |
| Confidence Interval |
(2-Sided) 95% -22.0 to -11.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.8 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13.0 | |
| Confidence Interval |
(2-Sided) 95% -18.0 to -7.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13.0 | |
| Confidence Interval |
(2-Sided) 95% -18.0 to -8.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.052 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -5.0 | |
| Confidence Interval |
(2-Sided) 95% -11.0 to 0.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 |
|---|---|
| Description | The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement. |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
66.0
(21.6)
|
67.0
(21.7)
|
68.0
(19.9)
|
| Change from Baseline at Week 4 |
-22.0
(24.2)
|
-20.0
(26.3)
|
-8.0
(22.6)
|
| Change from Baseline at Week 12 |
-30.0
(27.9)
|
-27.0
(30.9)
|
-14.0
(27.0)
|
| Change from Baseline at Week 24 |
-37.0
(28.1)
|
-35.0
(29.1)
|
-24.0
(28.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -16.0 | |
| Confidence Interval |
(2-Sided) 95% -21.0 to -10.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -14.0 | |
| Confidence Interval |
(2-Sided) 95% -19.0 to -8.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.7 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -17.0 | |
| Confidence Interval |
(2-Sided) 95% -23.0 to -11.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.1 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -13.0 | |
| Confidence Interval |
(2-Sided) 95% -19.0 to -7.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.1 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -16.0 | |
| Confidence Interval |
(2-Sided) 95% -23.0 to -10.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.4 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -12.0 | |
| Confidence Interval |
(2-Sided) 95% -19.0 to -5.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.4 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 |
|---|---|
| Description | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
1.70
(0.656)
|
1.64
(0.683)
|
1.65
(0.633)
|
| Change from Baseline at Week 4 |
-0.39
(0.493)
|
-0.32
(0.539)
|
-0.18
(0.444)
|
| Change from Baseline at Week 24 |
-0.75
(0.620)
|
-0.60
(0.660)
|
-0.42
(0.600)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.055 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.055 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to -0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 |
|---|---|
| Description | |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
17.21
(18.275)
|
21.49
(28.206)
|
16.42
(18.321)
|
| Change from Baseline at Week 4 |
-9.55
(18.421)
|
-12.15
(25.502)
|
1.04
(13.942)
|
| Change from Baseline at Week 12 |
-11.86
(19.760)
|
-12.02
(26.226)
|
0.57
(15.178)
|
| Change from Baseline at Week 24 |
-10.87
(19.083)
|
-11.12
(27.766)
|
-1.50
(15.889)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.51 | |
| Confidence Interval |
(2-Sided) 95% -13.61 to -7.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.578 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -8.92 | |
| Confidence Interval |
(2-Sided) 95% -12.02 to -5.82 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.577 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.94 | |
| Confidence Interval |
(2-Sided) 95% -14.19 to -7.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.652 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -8.98 | |
| Confidence Interval |
(2-Sided) 95% -12.22 to -5.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.651 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -9.87 | |
| Confidence Interval |
(2-Sided) 95% -13.73 to -6.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.964 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -6.89 | |
| Confidence Interval |
(2-Sided) 95% -10.80 to -2.98 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.987 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 |
|---|---|
| Description | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
60.4
41.1%
|
54.7
35.8%
|
40.3
27.2%
|
| Week 12 |
66.7
45.4%
|
66.2
43.3%
|
44.4
30%
|
| Week 24 |
68.8
46.8%
|
54.1
35.4%
|
35.4
23.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 20.1 | |
| Confidence Interval |
(2-Sided) 95% 8.1 to 32.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 14.5 | |
| Confidence Interval |
(2-Sided) 95% 2.4 to 26.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 22.2 | |
| Confidence Interval |
(2-Sided) 95% 10.3 to 34.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 21.8 | |
| Confidence Interval |
(2-Sided) 95% 10.0 to 33.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 33.3 | |
| Confidence Interval |
(2-Sided) 95% 21.8 to 44.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 18.6 | |
| Confidence Interval |
(2-Sided) 95% 6.8 to 30.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 |
|---|---|
| Description | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
5.9
(1.03)
|
5.9
(0.98)
|
5.9
(0.86)
|
| Change from Baseline at Week 4 |
-1.7
(1.16)
|
-1.5
(1.14)
|
-0.9
(1.14)
|
| Change from Baseline at Week 12 |
-2.4
(1.32)
|
-2.3
(1.38)
|
-1.3
(1.33)
|
| Change from Baseline at Week 24 |
-2.9
(1.29)
|
-2.6
(1.32)
|
-2.1
(1.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.9 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to -0.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.7 | |
| Confidence Interval |
(2-Sided) 95% -0.9 to -0.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.13 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.2 | |
| Confidence Interval |
(2-Sided) 95% -1.5 to -0.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.0 | |
| Confidence Interval |
(2-Sided) 95% -1.3 to -0.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.15 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.1 | |
| Confidence Interval |
(2-Sided) 95% -1.5 to -0.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.7 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to -0.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 |
|---|---|
| Description | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
21.8
14.8%
|
22.2
14.5%
|
9.5
6.4%
|
| Week 24 |
48.3
32.9%
|
37.9
24.8%
|
20.9
14.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 12.3 | |
| Confidence Interval |
(2-Sided) 95% 3.5 to 21.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 12.8 | |
| Confidence Interval |
(2-Sided) 95% 4.0 to 21.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 24. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 27.4 | |
| Confidence Interval |
(2-Sided) 95% 16.3 to 38.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 24. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 17.0 | |
| Confidence Interval |
(2-Sided) 95% 6.2 to 27.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 |
|---|---|
| Description | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
10.2
6.9%
|
11.8
7.7%
|
2.7
1.8%
|
| Week 12 |
22.4
15.2%
|
25.5
16.7%
|
8.1
5.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 7.5 | |
| Confidence Interval |
(2-Sided) 95% 1.3 to 13.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 4. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 9.1 | |
| Confidence Interval |
(2-Sided) 95% 2.7 to 15.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 200 mg vs Placebo at Week 12. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 14.3 | |
| Confidence Interval |
(2-Sided) 95% 5.6 to 23.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | Filgotinib 100 mg vs Placebo at Week 12. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value was calculated from the logistic regression with treatment groups and stratification factors in the model. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 17.4 | |
| Confidence Interval |
(2-Sided) 95% 8.5 to 26.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 |
|---|---|
| Description | ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
26.9
(24.58)
|
25.8
(27.09)
|
13.7
(19.42)
|
| Week 12 |
43.4
(29.26)
|
37.1
(30.29)
|
19.7
(25.44)
|
| Week 24 |
53.5
(27.52)
|
45.5
(32.16)
|
31.9
(29.52)
|
| Title | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 |
|---|---|
| Description | Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Good Response |
32
21.8%
|
34
22.2%
|
13
8.8%
|
| Moderate Response |
74
50.3%
|
65
42.5%
|
53
35.8%
|
| No Response |
38
25.9%
|
46
30.1%
|
63
42.6%
|
| Good Response |
58
39.5%
|
56
36.6%
|
23
15.5%
|
| Moderate Response |
65
44.2%
|
58
37.9%
|
51
34.5%
|
| No Response |
13
8.8%
|
23
15%
|
54
36.5%
|
| Good Response |
70
47.6%
|
58
37.9%
|
31
20.9%
|
| Moderate Response |
43
29.3%
|
47
30.7%
|
45
30.4%
|
| No Response |
8
5.4%
|
6
3.9%
|
12
8.1%
|
| Title | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
41.7
(14.23)
|
40.4
(13.23)
|
41.4
(12.00)
|
| Change from Baseline at Week 4 |
-19.1
(13.06)
|
-16.8
(12.95)
|
-12.8
(13.71)
|
| Change from Baseline at Week 12 |
-26.2
(15.04)
|
-23.8
(14.33)
|
-17.3
(15.22)
|
| Change from Baseline at Week 24 |
-30.9
(13.77)
|
-27.8
(13.54)
|
-25.4
(14.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -7.1 | |
| Confidence Interval |
(2-Sided) 95% -10.0 to -4.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.47 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -5.0 | |
| Confidence Interval |
(2-Sided) 95% -7.9 to -2.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.46 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -9.5 | |
| Confidence Interval |
(2-Sided) 95% -12.6 to -6.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.56 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -7.6 | |
| Confidence Interval |
(2-Sided) 95% -10.6 to -4.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.55 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -8.7 | |
| Confidence Interval |
(2-Sided) 95% -11.9 to -5.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.64 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -4.9 | |
| Confidence Interval |
(2-Sided) 95% -8.2 to -1.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.66 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 |
|---|---|
| Description | SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement. |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Baseline |
43.4
(14.64)
|
42.6
(14.16)
|
43.0
(12.33)
|
| Change from Baseline at Week 4 |
-20.1
(13.73)
|
-18.1
(13.19)
|
-12.9
(14.01)
|
| Change from Baseline at Week 12 |
-27.6
(15.54)
|
-24.9
(15.01)
|
-17.2
(15.52)
|
| Change from Baseline at Week 24 |
-32.1
(14.41)
|
-28.8
(14.19)
|
-24.9
(14.84)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -8.1 | |
| Confidence Interval |
(2-Sided) 95% -11.1 to -5.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.52 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -5.9 | |
| Confidence Interval |
(2-Sided) 95% -8.9 to -2.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.52 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.7 | |
| Confidence Interval |
(2-Sided) 95% -13.8 to -7.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.60 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -8.7 | |
| Confidence Interval |
(2-Sided) 95% -11.8 to -5.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.59 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -10.1 | |
| Confidence Interval |
(2-Sided) 95% -13.5 to -6.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.70 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -6.1 | |
| Confidence Interval |
(2-Sided) 95% -9.4 to -2.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.71 |
|
| Estimation Comments | ||
| Title | SF-36 PCS Score at Weeks 4, 12, and 24 |
|---|---|
| Description | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
35.4
(8.72)
|
36.4
(9.29)
|
33.7
(8.67)
|
| Week 12 |
38.3
(10.14)
|
38.6
(9.39)
|
35.1
(9.90)
|
| Week 24 |
40.4
(9.64)
|
40.3
(10.31)
|
37.7
(9.09)
|
| Title | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 |
|---|---|
| Description | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Time Frame | Baseline; Weeks 4, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 153 | 148 |
| Baseline |
30.4
(7.75)
|
31.7
(7.76)
|
31.1
(8.17)
|
| Change from Baseline at Week 4 |
5.1
(6.34)
|
4.5
(6.53)
|
2.5
(5.91)
|
| Change from Baseline at Week 24 |
9.4
(8.23)
|
9.0
(8.44)
|
6.6
(7.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 2.5 | |
| Confidence Interval |
(2-Sided) 95% 1.1 to 3.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.70 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 2.0 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 3.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.70 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.9 | |
| Confidence Interval |
(2-Sided) 95% 1.9 to 5.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.02 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.1 | |
| Confidence Interval |
(2-Sided) 95% 1.1 to 5.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
| Estimation Comments | ||
| Title | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 |
|---|---|
| Description | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
48.0
(11.48)
|
47.3
(11.51)
|
45.5
(11.11)
|
| Week 12 |
50.2
(10.58)
|
48.8
(11.02)
|
47.9
(11.01)
|
| Week 24 |
50.6
(10.35)
|
49.5
(10.72)
|
49.1
(10.56)
|
| Title | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 |
|---|---|
| Description | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 153 | 148 |
| Baseline |
44.5
(11.97)
|
44.2
(11.59)
|
44.3
(11.32)
|
| Change from Baseline at Week 4 |
3.5
(9.17)
|
3.0
(9.03)
|
1.2
(9.34)
|
| Change from Baseline at Week 12 |
5.3
(10.60)
|
4.6
(9.76)
|
3.7
(9.17)
|
| Change from Baseline at Week 24 |
6.5
(12.50)
|
4.6
(9.22)
|
4.3
(9.44)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.019 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 2.3 | |
| Confidence Interval |
(2-Sided) 95% 0.4 to 4.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.97 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.073 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 1.7 | |
| Confidence Interval |
(2-Sided) 95% -0.2 to 3.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.97 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 2.1 | |
| Confidence Interval |
(2-Sided) 95% 0.0 to 4.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.32 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 1.0 | |
| Confidence Interval |
(2-Sided) 95% -1.0 to 3.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.02 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 1.9 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 4.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.19 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -2.3 to 2.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.20 |
|
| Estimation Comments | ||
| Title | FACIT-Fatigue Score at Weeks 4, 12, and 24 |
|---|---|
| Description | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
30.4
(12.48)
|
30.3
(12.30)
|
27.9
(11.29)
|
| Week 12 |
34.0
(12.08)
|
32.1
(13.66)
|
30.4
(11.79)
|
| Week 24 |
36.3
(11.58)
|
34.4
(12.51)
|
33.3
(11.26)
|
| Title | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 |
|---|---|
| Description | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Time Frame | Baseline; Weeks 4, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 152 | 147 |
| Baseline |
24.2
(11.47)
|
23.7
(12.30)
|
25.4
(10.89)
|
| Change from Baseline at Week 4 |
6.2
(10.20)
|
6.4
(9.87)
|
2.2
(8.92)
|
| Change from Baseline at Week 24 |
11.6
(11.67)
|
9.8
(10.39)
|
7.0
(10.23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.7 | |
| Confidence Interval |
(2-Sided) 95% 1.6 to 5.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.05 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 3.3 | |
| Confidence Interval |
(2-Sided) 95% 1.2 to 5.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.05 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 4.6 | |
| Confidence Interval |
(2-Sided) 95% 2.1 to 7.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.28 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 2.1 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 4.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.30 |
|
| Estimation Comments | ||
| Title | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 |
|---|---|
| Description | The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| No Problems |
34
23.1%
|
45
29.4%
|
32
21.6%
|
| Slight Problems |
58
39.5%
|
49
32%
|
49
33.1%
|
| Moderate Problems |
38
25.9%
|
33
21.6%
|
36
24.3%
|
| Severe Problems |
15
10.2%
|
16
10.5%
|
25
16.9%
|
| Extreme Problems |
0
0%
|
1
0.7%
|
2
1.4%
|
| No Problems |
47
32%
|
57
37.3%
|
38
25.7%
|
| Slight Problems |
55
37.4%
|
48
31.4%
|
46
31.1%
|
| Moderate Problems |
25
17%
|
29
19%
|
29
19.6%
|
| Severe Problems |
13
8.8%
|
9
5.9%
|
19
12.8%
|
| Extreme Problems |
1
0.7%
|
0
0%
|
0
0%
|
| No Problems |
51
34.7%
|
38
24.8%
|
32
21.6%
|
| Slight Problems |
38
25.9%
|
45
29.4%
|
29
19.6%
|
| Moderate Problems |
23
15.6%
|
18
11.8%
|
24
16.2%
|
| Severe Problems |
11
7.5%
|
8
5.2%
|
5
3.4%
|
| Extreme Problems |
0
0%
|
1
0.7%
|
0
0%
|
| No Problems |
67
45.6%
|
67
43.8%
|
49
33.1%
|
| Slight Problems |
45
30.6%
|
43
28.1%
|
52
35.1%
|
| Moderate Problems |
24
16.3%
|
27
17.6%
|
28
18.9%
|
| Severe Problems |
6
4.1%
|
6
3.9%
|
11
7.4%
|
| Extreme Problems |
3
2%
|
1
0.7%
|
4
2.7%
|
| No Problems |
79
53.7%
|
78
51%
|
56
37.8%
|
| Slight Problems |
38
25.9%
|
46
30.1%
|
44
29.7%
|
| Moderate Problems |
16
10.9%
|
15
9.8%
|
21
14.2%
|
| Severe Problems |
6
4.1%
|
4
2.6%
|
11
7.4%
|
| Extreme Problems |
2
1.4%
|
0
0%
|
0
0%
|
| No Problems |
83
56.5%
|
58
37.9%
|
45
30.4%
|
| Slight Problems |
23
15.6%
|
31
20.3%
|
31
20.9%
|
| Moderate Problems |
13
8.8%
|
16
10.5%
|
10
6.8%
|
| Severe Problems |
4
2.7%
|
4
2.6%
|
4
2.7%
|
| Extreme Problems |
0
0%
|
1
0.7%
|
0
0%
|
| No Problems |
27
18.4%
|
38
24.8%
|
22
14.9%
|
| Slight Problems |
65
44.2%
|
50
32.7%
|
44
29.7%
|
| Moderate Problems |
26
17.7%
|
38
24.8%
|
49
33.1%
|
| Severe Problems |
19
12.9%
|
12
7.8%
|
25
16.9%
|
| Extreme Problems |
8
5.4%
|
6
3.9%
|
4
2.7%
|
| No Problems |
47
32%
|
51
33.3%
|
26
17.6%
|
| Slight Problems |
54
36.7%
|
41
26.8%
|
48
32.4%
|
| Moderate Problems |
25
17%
|
37
24.2%
|
38
25.7%
|
| Severe Problems |
15
10.2%
|
11
7.2%
|
20
13.5%
|
| Extreme Problems |
0
0%
|
3
2%
|
0
0%
|
| No Problems |
51
34.7%
|
41
26.8%
|
20
13.5%
|
| Slight Problems |
45
30.6%
|
32
20.9%
|
41
27.7%
|
| Moderate Problems |
18
12.2%
|
28
18.3%
|
24
16.2%
|
| Severe Problems |
8
5.4%
|
7
4.6%
|
4
2.7%
|
| Extreme Problems |
1
0.7%
|
2
1.3%
|
1
0.7%
|
| No Problems |
8
5.4%
|
11
7.2%
|
3
2%
|
| Slight Problems |
69
46.9%
|
57
37.3%
|
37
25%
|
| Moderate Problems |
45
30.6%
|
50
32.7%
|
62
41.9%
|
| Severe Problems |
19
12.9%
|
22
14.4%
|
36
24.3%
|
| Extreme Problems |
4
2.7%
|
4
2.6%
|
6
4.1%
|
| No Problems |
21
14.3%
|
16
10.5%
|
10
6.8%
|
| Slight Problems |
68
46.3%
|
56
36.6%
|
36
24.3%
|
| Moderate Problems |
34
23.1%
|
56
36.6%
|
57
38.5%
|
| Severe Problems |
17
11.6%
|
14
9.2%
|
28
18.9%
|
| Extreme Problems |
1
0.7%
|
1
0.7%
|
1
0.7%
|
| No Problems |
18
12.2%
|
20
13.1%
|
10
6.8%
|
| Slight Problems |
61
41.5%
|
42
27.5%
|
32
21.6%
|
| Moderate Problems |
31
21.1%
|
36
23.5%
|
33
22.3%
|
| Severe Problems |
12
8.2%
|
10
6.5%
|
14
9.5%
|
| Extreme Problems |
1
0.7%
|
2
1.3%
|
1
0.7%
|
| No Problems |
78
53.1%
|
77
50.3%
|
60
40.5%
|
| Slight Problems |
33
22.4%
|
41
26.8%
|
43
29.1%
|
| Moderate Problems |
25
17%
|
21
13.7%
|
34
23%
|
| Severe Problems |
8
5.4%
|
4
2.6%
|
5
3.4%
|
| Extreme Problems |
1
0.7%
|
1
0.7%
|
2
1.4%
|
| No Problems |
79
53.7%
|
84
54.9%
|
71
48%
|
| Slight Problems |
33
22.4%
|
30
19.6%
|
34
23%
|
| Moderate Problems |
23
15.6%
|
26
17%
|
23
15.5%
|
| Severe Problems |
5
3.4%
|
3
2%
|
3
2%
|
| Extreme Problems |
1
0.7%
|
0
0%
|
1
0.7%
|
| No Problems |
70
47.6%
|
62
40.5%
|
50
33.8%
|
| Slight Problems |
33
22.4%
|
30
19.6%
|
19
12.8%
|
| Moderate Problems |
16
10.9%
|
13
8.5%
|
15
10.1%
|
| Severe Problems |
4
2.7%
|
4
2.6%
|
6
4.1%
|
| Extreme Problems |
0
0%
|
1
0.7%
|
0
0%
|
| Title | EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
|---|---|
| Description | EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| Time Frame | Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
59.0
(22.1)
|
60.0
(19.8)
|
52.0
(24.2)
|
| Week 12 |
66.0
(23.2)
|
65.0
(22.2)
|
58.0
(23.0)
|
| Week 24 |
70.0
(21.8)
|
69.0
(21.3)
|
62.0
(23.0)
|
| Title | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
|---|---|
| Description | The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health). |
| Time Frame | Baseline; Weeks 4, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 152 | 147 |
| Baseline |
49.0
(24.7)
|
46.0
(24.0)
|
46.0
(22.4)
|
| Change from Baseline at Week 4 |
10.0
(27.6)
|
14.0
(26.8)
|
6.0
(26.0)
|
| Change from Baseline at Week 12 |
17.0
(30.9)
|
19.0
(26.4)
|
12.0
(26.5)
|
| Change from Baseline at Week 24 |
22.0
(30.8)
|
25.0
(26.7)
|
17.0
(25.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 6.0 | |
| Confidence Interval |
(2-Sided) 95% 2.0 to 11.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.5 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 7.0 | |
| Confidence Interval |
(2-Sided) 95% 3.0 to 12.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.5 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 8.0 | |
| Confidence Interval |
(2-Sided) 95% 3.0 to 13.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.6 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 7.0 | |
| Confidence Interval |
(2-Sided) 95% 2.0 to 12.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.6 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 200 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 9.0 | |
| Confidence Interval |
(2-Sided) 95% 3.0 to 15.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.9 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Filgotinib 100 mg, Placebo |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 8.0 | |
| Confidence Interval |
(2-Sided) 95% 2.0 to 14.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.9 |
|
| Estimation Comments | ||
| Title | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
8.8
(21.01)
|
18.2
(30.93)
|
14.3
(27.52)
|
| Week 12 |
5.6
(13.79)
|
14.6
(27.13)
|
12.1
(24.39)
|
| Week 24 |
7.6
(16.37)
|
13.8
(26.23)
|
8.5
(18.08)
|
| Title | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
27.4
(22.50)
|
37.8
(25.43)
|
48.6
(29.81)
|
| Week 12 |
23.9
(20.99)
|
34.8
(27.22)
|
44.2
(29.21)
|
| Week 24 |
28.0
(27.57)
|
25.6
(22.10)
|
36.7
(26.95)
|
| Title | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
30.8
(24.36)
|
43.1
(27.82)
|
51.3
(30.85)
|
| Week 12 |
26.9
(24.20)
|
39.5
(29.37)
|
46.9
(30.63)
|
| Week 24 |
31.7
(29.94)
|
31.4
(25.65)
|
39.8
(29.49)
|
| Title | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 147 | 153 | 148 |
| Week 4 |
49.6
(26.56)
|
49.9
(27.43)
|
60.3
(25.49)
|
| Week 12 |
40.3
(26.75)
|
45.5
(28.23)
|
53.0
(27.26)
|
| Week 24 |
33.3
(24.61)
|
37.5
(27.00)
|
45.7
(25.57)
|
| Title | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 35 | 54 | 48 |
| Baseline |
11.3
(16.31)
|
19.2
(28.57)
|
10.8
(25.65)
|
| Change from Baseline at Week 4 |
-4.3
(20.98)
|
-3.4
(24.57)
|
4.0
(20.75)
|
| Change from Baseline at Week 12 |
-3.6
(17.60)
|
-7.0
(30.93)
|
3.8
(18.40)
|
| Change from Baseline at Week 24 |
-4.6
(22.50)
|
-3.1
(34.28)
|
3.7
(25.13)
|
| Title | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 35 | 51 | 46 |
| Baseline |
46.9
(24.71)
|
51.0
(27.95)
|
55.7
(26.64)
|
| Change from Baseline at Week 4 |
-19.1
(25.63)
|
-13.1
(25.75)
|
-5.3
(25.52)
|
| Change from Baseline at Week 12 |
-20.0
(25.56)
|
-18.8
(28.64)
|
-10.8
(20.32)
|
| Change from Baseline at Week 24 |
-18.6
(22.48)
|
-28.7
(25.26)
|
-20.0
(31.36)
|
| Title | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 35 | 51 | 46 |
| Baseline |
52.0
(24.02)
|
55.8
(30.53)
|
56.7
(27.60)
|
| Change from Baseline at Week 4 |
-20.9
(28.94)
|
-12.3
(28.05)
|
-3.4
(25.48)
|
| Change from Baseline at Week 12 |
-22.8
(29.20)
|
-19.5
(31.49)
|
-8.3
(20.16)
|
| Change from Baseline at Week 24 |
-20.5
(26.20)
|
-26.4
(29.87)
|
-16.7
(33.28)
|
| Title | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. |
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. |
| Measure Participants | 146 | 152 | 147 |
| Baseline |
65.6
(22.16)
|
64.6
(23.07)
|
65.4
(23.33)
|
| Change from Baseline at Week 4 |
-16.0
(24.64)
|
-14.3
(22.89)
|
-4.7
(25.06)
|
| Change from Baseline at Week 12 |
-25.0
(26.81)
|
-19.2
(28.32)
|
-11.3
(25.75)
|
| Change from Baseline at Week 24 |
-32.5
(27.37)
|
-27.1
(27.97)
|
-18.4
(31.23)
|
Adverse Events
| Time Frame | First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | |||||
| Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | |||
| Arm/Group Description | 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. | 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. | 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. | |||
All Cause Mortality |
||||||
| Filgotinib 200 mg | Filgotinib 100 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/147 (0%) | 0/153 (0%) | 0/148 (0%) | |||
Serious Adverse Events |
||||||
| Filgotinib 200 mg | Filgotinib 100 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/147 (4.1%) | 8/153 (5.2%) | 5/148 (3.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Cardiac disorders | ||||||
| Myocardial ischaemia | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Nausea | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Vomiting | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| General disorders | ||||||
| Chest pain | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Systemic inflammatory response syndrome | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Infections and infestations | ||||||
| Abscess oral | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Bronchitis | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Cellulitis | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Gallbladder empyema | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Gastroenteritis | 0/147 (0%) | 0/153 (0%) | 2/148 (1.4%) | |||
| Vulval abscess | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Concussion | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Laceration | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Lumbar vertebral fracture | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Rib fracture | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Subarachnoid haemorrhage | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 1/147 (0.7%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Hyponatraemia | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Lactic acidosis | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Bursitis | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Lumbar spinal stenosis | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Osteitis | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Rheumatoid arthritis | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Psychiatric disorders | ||||||
| Depression | 0/147 (0%) | 1/153 (0.7%) | 0/148 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Uterine haemorrhage | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 0/147 (0%) | 0/153 (0%) | 1/148 (0.7%) | |||
| Pulmonary oedema | 1/147 (0.7%) | 0/153 (0%) | 0/148 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Filgotinib 200 mg | Filgotinib 100 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 39/147 (26.5%) | 35/153 (22.9%) | 31/148 (20.9%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 7/147 (4.8%) | 8/153 (5.2%) | 5/148 (3.4%) | |||
| Infections and infestations | ||||||
| Bronchitis | 8/147 (5.4%) | 3/153 (2%) | 8/148 (5.4%) | |||
| Nasopharyngitis | 15/147 (10.2%) | 9/153 (5.9%) | 7/148 (4.7%) | |||
| Upper respiratory tract infection | 8/147 (5.4%) | 9/153 (5.9%) | 6/148 (4.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Rheumatoid arthritis | 2/147 (1.4%) | 2/153 (1.3%) | 8/148 (5.4%) | |||
| Nervous system disorders | ||||||
| Headache | 8/147 (5.4%) | 9/153 (5.9%) | 2/148 (1.4%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Results Point of Contact
| Name/Title | Gilead Clinical Study Information Center |
|---|---|
| Organization | Gilead Sciences |
| Phone | 1-833-445-3230 (GILEAD-0) |
| GileadClinicalTrials@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02873936
Other Study ID Numbers:
- GS-US-417-0302
- 2016-000569-21
First Posted:
Aug 22, 2016
Last Update Posted:
May 13, 2021
Last Verified:
Apr 1, 2021