Rheumatoid Arthritis
Conditions
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
Interventions
DRUGFilgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Tablet(s) administered orally once daily
DRUGAdalimumab
40 mg administered via subcutaneous injection once every two weeks
Administered via subcutaneous injection once every two weeks
DRUGMTX
Commercially sourced tablet(s) administered orally
Sponsors
Galapagos NV
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have a diagnosis of rheumatoid arthritis (RA) \[2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria\] , and are ACR functional class I-III. * Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1. * Ongoing treatment with a stable dose of MTX Key
Exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 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)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 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), SGA (VAS: 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 Modified Total Sharp Score (mTSS) at Week 24 | Baseline; Week 24 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). |
| Percentage of Participants Who Achieved 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), 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. |
| 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. |
| 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 2, 4, 12, and 24 | Weeks 2, 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 ACR50 at Weeks 36, and 52 | Weeks 36, and 52 | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Weeks 2, 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 ACR70 at Weeks 36, and 52 | Weeks 36, and 52 | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Weeks 2, 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. |
| Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Weeks 36, and 52 | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline; Weeks 2, 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: HAQ-DI at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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: TJC68 at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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: SJC66 at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s (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 2, 4, 12, and 24 | Baseline; Weeks 2, 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: SGA at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 4, 12, and 24 | PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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: Subject's Pain Assessment at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement. |
| Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 4, 12, and 24 | — |
| Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | — |
| Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Weeks 2, 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. |
| Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Weeks 36, and 52 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders. |
| Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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. |
| Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 2, 4, and 24 | Weeks 2, 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) ≤ 3.2 at Weeks 36, and 52 | Weeks 36, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 2, 4, and 24 | Weeks 2, 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 36, and 52 | Weeks 36, and 52 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 2, 4, 12, and 24 | Weeks 2, 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. |
| ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Weeks 36, and 52 | ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and 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 2, 4, 12, and 24 | Weeks 2, 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. |
| Number of Participants With EULAR Response at Weeks 36, and 52 | Weeks 36, and 52 | Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>0.6 and ≤1.2; DAS28(CRP) at visit \>3.2 and ≤5.1 and improvement from baseline \>0.6; DAS 28(CRP) at visit \>5.1 and improvement from baseline \>1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) \>5.1 at visit and improvement from baseline ≤1.2. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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 CDAI at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 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. |
| Change From Baseline in SDAI at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement. |
| Change From Baseline in mTSS at Week 52 | Baseline; Week 52 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). |
| Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Baseline; Weeks 24 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC). |
| Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Baseline; Week 52 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC). |
| 36-Item Short Form Survey (SF-36) Physical Component Summary (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. |
| SF-36 PCS Score at Weeks 36, and 52 | Weeks 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Change From Baseline in SF-36 PCS Score at Weeks 4, 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. |
| Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 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. |
| SF-36 MCS Score at Weeks 36, and 52 | Weeks 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. |
| Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 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. |
| Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Functional Assessment of Chronic Illness Therapy (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. |
| FACIT-Fatigue Score at Weeks 36, and 52 | Weeks 36, and 52 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 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). |
| Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 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. |
| Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Weeks 36, and 52 | The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| EQ-5D Current Health VAS at Weeks 4, 12, 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. |
| EQ-5D Current Health VAS at Weeks 36, and 52 | Weeks 36, and 52 | EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. |
| Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 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). |
| Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health). |
| Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 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 Work Time Missed (Absenteeism) at Weeks 36, and 52 | Weeks 36, and 52 | 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 Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Weeks 36, and 52 | 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 Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Weeks 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline; Week 12 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (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). 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). |
| WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Weeks 36, and 52 | 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 Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | 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 Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | 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 Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | 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. |
| Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. |
| WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Weeks 4, 12, and 24 | The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019.
Pre-assignment details
2582 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Filgotinib 200 mg Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | 475 |
| Filgotinib 100 mg Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | 480 |
| Adalimumab Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | 325 |
| Placebo The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups. | 475 |
| Total | 1,755 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 17 | 8 | 8 | 4 | 1 | 7 |
| Overall Study | Death | 1 | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Investigator's Discretion | 10 | 9 | 10 | 3 | 0 | 15 |
| Overall Study | Lost to Follow-up | 5 | 7 | 2 | 0 | 2 | 6 |
| Overall Study | Non-compliance With Study Drug | 0 | 2 | 0 | 0 | 1 | 2 |
| Overall Study | Pregnancy | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 3 | 0 | 0 | 4 |
| Overall Study | Randomized but not Dosed | 2 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrew Consent | 18 | 29 | 20 | 1 | 2 | 35 |
Baseline characteristics
| Characteristic | Filgotinib 200 mg | Total | Placebo | Adalimumab | Filgotinib 100 mg |
|---|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12.8 | 53 years STANDARD_DEVIATION 12.7 | 53 years STANDARD_DEVIATION 12.8 | 53 years STANDARD_DEVIATION 12.9 | 53 years STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 67 Participants | 262 Participants | 70 Participants | 54 Participants | 71 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 404 Participants | 1471 Participants | 400 Participants | 268 Participants | 399 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 4 Participants | 22 Participants | 5 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 27 Participants | 103 Participants | 29 Participants | 20 Participants | 27 Participants |
| Race/Ethnicity, Customized Race Asian: Chinese/Taiwanese/Hong Kong Chinese | 13 Participants | 51 Participants | 18 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Asian: Japanese | 40 Participants | 147 Participants | 38 Participants | 28 Participants | 41 Participants |
| Race/Ethnicity, Customized Race Asian: Korean | 13 Participants | 34 Participants | 7 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Asian: Other | 56 Participants | 179 Participants | 46 Participants | 25 Participants | 52 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants | 35 Participants | 12 Participants | 10 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Permitted | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 7 Participants | 17 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 312 Participants | 1184 Participants | 319 Participants | 229 Participants | 324 Participants |
| Region of Enrollment Argentina | 15 Participants | 57 Participants | 15 Participants | 10 Participants | 17 Participants |
| Region of Enrollment Australia | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Belgium | 2 Participants | 10 Participants | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment Bulgaria | 7 Participants | 34 Participants | 14 Participants | 6 Participants | 7 Participants |
| Region of Enrollment Canada | 4 Participants | 12 Participants | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment Czechia | 7 Participants | 34 Participants | 13 Participants | 7 Participants | 7 Participants |
| Region of Enrollment Germany | 5 Participants | 20 Participants | 4 Participants | 5 Participants | 6 Participants |
| Region of Enrollment Hong Kong | 1 Participants | 7 Participants | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Hungary | 12 Participants | 46 Participants | 17 Participants | 5 Participants | 12 Participants |
| Region of Enrollment India | 40 Participants | 137 Participants | 39 Participants | 19 Participants | 39 Participants |
| Region of Enrollment Ireland | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Israel | 4 Participants | 11 Participants | 4 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Italy | 2 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Japan | 40 Participants | 147 Participants | 38 Participants | 28 Participants | 41 Participants |
| Region of Enrollment Mexico | 33 Participants | 125 Participants | 34 Participants | 25 Participants | 33 Participants |
| Region of Enrollment Netherlands | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment New Zealand | 5 Participants | 18 Participants | 5 Participants | 3 Participants | 5 Participants |
| Region of Enrollment Poland | 78 Participants | 298 Participants | 74 Participants | 64 Participants | 82 Participants |
| Region of Enrollment Romania | 12 Participants | 31 Participants | 11 Participants | 2 Participants | 6 Participants |
| Region of Enrollment Russia | 34 Participants | 118 Participants | 30 Participants | 22 Participants | 32 Participants |
| Region of Enrollment Serbia | 1 Participants | 21 Participants | 5 Participants | 8 Participants | 7 Participants |
| Region of Enrollment Slovakia | 2 Participants | 8 Participants | 3 Participants | 1 Participants | 2 Participants |
| Region of Enrollment South Africa | 12 Participants | 34 Participants | 8 Participants | 3 Participants | 11 Participants |
| Region of Enrollment South Korea | 12 Participants | 33 Participants | 7 Participants | 4 Participants | 10 Participants |
| Region of Enrollment Spain | 14 Participants | 30 Participants | 7 Participants | 6 Participants | 3 Participants |
| Region of Enrollment Taiwan | 12 Participants | 44 Participants | 16 Participants | 7 Participants | 9 Participants |
| Region of Enrollment Thailand | 7 Participants | 23 Participants | 4 Participants | 6 Participants | 6 Participants |
| Region of Enrollment Ukraine | 66 Participants | 235 Participants | 55 Participants | 41 Participants | 73 Participants |
| Region of Enrollment United Kingdom | 1 Participants | 13 Participants | 6 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 47 Participants | 199 Participants | 60 Participants | 37 Participants | 55 Participants |
| Sex: Female, Male Female | 379 Participants | 1435 Participants | 391 Participants | 266 Participants | 399 Participants |
| Sex: Female, Male Male | 96 Participants | 320 Participants | 84 Participants | 59 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 475 | 1 / 480 | 1 / 325 | 1 / 190 | 1 / 191 | 2 / 475 |
| other Total, other adverse events | 128 / 475 | 142 / 480 | 82 / 325 | 36 / 190 | 23 / 191 | 61 / 475 |
| serious Total, serious adverse events | 35 / 475 | 40 / 480 | 22 / 325 | 7 / 190 | 8 / 191 | 21 / 475 |
Outcome results
Primary
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Time frame: Week 12
Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 76.6 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 69.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 70.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | 49.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [20.6, 32.8]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [13.6, 26.2]Regression, Logistic
Secondary
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 4 | 39.0 score on a scale | Standard Deviation 8.22 |
| Filgotinib 200 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 24 | 43.9 score on a scale | Standard Deviation 8.49 |
| Filgotinib 200 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 12 | 42.7 score on a scale | Standard Deviation 8.3 |
| Filgotinib 100 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 4 | 38.2 score on a scale | Standard Deviation 8.35 |
| Filgotinib 100 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 24 | 43.7 score on a scale | Standard Deviation 8.64 |
| Filgotinib 100 mg | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 12 | 42.1 score on a scale | Standard Deviation 8.69 |
| Adalimumab | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 12 | 41.3 score on a scale | Standard Deviation 8.57 |
| Adalimumab | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 4 | 37.7 score on a scale | Standard Deviation 8.07 |
| Adalimumab | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 24 | 43.2 score on a scale | Standard Deviation 8.95 |
| Placebo | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 4 | 36.1 score on a scale | Standard Deviation 7.4 |
| Placebo | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 24 | 40.7 score on a scale | Standard Deviation 8.1 |
| Placebo | 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 | Week 12 | 38.8 score on a scale | Standard Deviation 7.83 |
Secondary
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and 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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 36 | 62.5 percent improvement | Standard Deviation 26.01 |
| Filgotinib 200 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 52 | 66.0 percent improvement | Standard Deviation 25.89 |
| Filgotinib 100 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 36 | 59.1 percent improvement | Standard Deviation 27.47 |
| Filgotinib 100 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 52 | 63.1 percent improvement | Standard Deviation 26.34 |
| Adalimumab | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 36 | 58.6 percent improvement | Standard Deviation 27.17 |
| Adalimumab | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 52 | 63.5 percent improvement | Standard Deviation 27.03 |
| Placebo | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 52 | 63.8 percent improvement | Standard Deviation 28 |
| Placebo | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 36 | 63.2 percent improvement | Standard Deviation 24.59 |
| Placebo to Filgotinib 100 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 36 | 56.1 percent improvement | Standard Deviation 27.3 |
| Placebo to Filgotinib 100 mg | ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 | Week 52 | 59.7 percent improvement | Standard Deviation 26.81 |
Secondary
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Time frame: Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 2 | 18.3 percent improvement | Standard Deviation 19.98 |
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 4 | 27.4 percent improvement | Standard Deviation 25.24 |
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 12 | 46.8 percent improvement | Standard Deviation 28.46 |
| Filgotinib 200 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 24 | 58.8 percent improvement | Standard Deviation 27.76 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 4 | 23.0 percent improvement | Standard Deviation 22.26 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 12 | 40.6 percent improvement | Standard Deviation 27.32 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 24 | 55.4 percent improvement | Standard Deviation 26.47 |
| Filgotinib 100 mg | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 2 | 14.0 percent improvement | Standard Deviation 17.14 |
| Adalimumab | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 12 | 40.4 percent improvement | Standard Deviation 26.18 |
| Adalimumab | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 4 | 23.8 percent improvement | Standard Deviation 22.94 |
| Adalimumab | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 24 | 54.3 percent improvement | Standard Deviation 28.13 |
| Adalimumab | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 2 | 16.3 percent improvement | Standard Deviation 18.41 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 24 | 42.6 percent improvement | Standard Deviation 27.73 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 4 | 15.1 percent improvement | Standard Deviation 18.92 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 2 | 8.0 percent improvement | Standard Deviation 12.82 |
| Placebo | American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 | Week 12 | 28.1 percent improvement | Standard Deviation 25.22 |
Secondary
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 33.4 score on a scale | Standard Deviation 7.17 |
| Filgotinib 200 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 9.2 score on a scale | Standard Deviation 8.1 |
| Filgotinib 100 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 8.5 score on a scale | Standard Deviation 7.72 |
| Filgotinib 100 mg | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 33.6 score on a scale | Standard Deviation 7.75 |
| Adalimumab | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 32.8 score on a scale | Standard Deviation 7.74 |
| Adalimumab | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 8.4 score on a scale | Standard Deviation 7.89 |
| Placebo | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline | 32.9 score on a scale | Standard Deviation 7.11 |
| Placebo | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Change from Baseline at Week 12 | 5.8 score on a scale | Standard Deviation 7.1 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.8, 4.6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.2, 4]MMRM
Secondary
Change From Baseline in CDAI at Weeks 36, and 52
CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Baseline | 39.5 score on a scale | Standard Deviation 11.85 |
| Filgotinib 200 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.9 score on a scale | Standard Deviation 11.69 |
| Filgotinib 200 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -32.1 score on a scale | Standard Deviation 11.6 |
| Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -29.9 score on a scale | Standard Deviation 12.18 |
| Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Baseline | 38.6 score on a scale | Standard Deviation 12.23 |
| Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -30.9 score on a scale | Standard Deviation 11.7 |
| Adalimumab | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -30.4 score on a scale | Standard Deviation 11.21 |
| Adalimumab | Change From Baseline in CDAI at Weeks 36, and 52 | Baseline | 39.2 score on a scale | Standard Deviation 11.51 |
| Adalimumab | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -31.6 score on a scale | Standard Deviation 11.44 |
| Placebo | Change From Baseline in CDAI at Weeks 36, and 52 | Baseline | 41.4 score on a scale | Standard Deviation 11.03 |
| Placebo | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -34.0 score on a scale | Standard Deviation 11.2 |
| Placebo | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -33.8 score on a scale | Standard Deviation 11.15 |
| Placebo to Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -29.0 score on a scale | Standard Deviation 11.02 |
| Placebo to Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Baseline | 37.8 score on a scale | Standard Deviation 11.23 |
| Placebo to Filgotinib 100 mg | Change From Baseline in CDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -30.7 score on a scale | Standard Deviation 10.8 |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -26.0 score on a scale | Standard Deviation 12.41 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -12.7 score on a scale | Standard Deviation 11.86 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -30.6 score on a scale | Standard Deviation 11.88 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -17.6 score on a scale | Standard Deviation 12.66 |
| Filgotinib 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Baseline | 39.5 score on a scale | Standard Deviation 11.85 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -15.6 score on a scale | Standard Deviation 12.07 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -23.3 score on a scale | Standard Deviation 12.32 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -28.6 score on a scale | Standard Deviation 11.57 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -10.7 score on a scale | Standard Deviation 11.17 |
| Filgotinib 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Baseline | 38.6 score on a scale | Standard Deviation 12.23 |
| Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -15.4 score on a scale | Standard Deviation 11.13 |
| Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Baseline | 39.2 score on a scale | Standard Deviation 11.51 |
| Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -11.7 score on a scale | Standard Deviation 10.06 |
| Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -23.5 score on a scale | Standard Deviation 11.43 |
| Adalimumab | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -28.4 score on a scale | Standard Deviation 11.45 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -20.3 score on a scale | Standard Deviation 13.3 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -8.2 score on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Baseline | 39.6 score on a scale | Standard Deviation 11.66 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -12.4 score on a scale | Standard Deviation 11.79 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -26.3 score on a scale | Standard Deviation 12.38 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.9, -3.2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4.3, -1.6]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.6, -3.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.3, -2.4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.3, -4.6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.8, -3.1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.9, -4.5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5.3, -2.9]MMRM
Secondary
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -2.5 score on a scale | Standard Deviation 1.24 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -1.3 score on a scale | Standard Deviation 1.05 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -3.1 score on a scale | Standard Deviation 1.17 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -1.7 score on a scale | Standard Deviation 1.19 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Baseline | 5.8 score on a scale | Standard Deviation 0.88 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -1.4 score on a scale | Standard Deviation 1.07 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -2.2 score on a scale | Standard Deviation 1.17 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -2.8 score on a scale | Standard Deviation 1.08 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -1.0 score on a scale | Standard Deviation 0.9 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Baseline | 5.7 score on a scale | Standard Deviation 0.95 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -1.4 score on a scale | Standard Deviation 1.04 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Baseline | 5.7 score on a scale | Standard Deviation 0.88 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -1.1 score on a scale | Standard Deviation 0.9 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -2.2 score on a scale | Standard Deviation 1.12 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -2.7 score on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -1.6 score on a scale | Standard Deviation 1.19 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -0.6 score on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Baseline | 5.7 score on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -0.9 score on a scale | Standard Deviation 0.98 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -2.2 score on a scale | Standard Deviation 1.2 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.5, -0.3]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.9, -0.7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.7, -0.4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.1, -0.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.8, -0.5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-1.1, -0.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.8, -0.5]MMRM
Secondary
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline | 5.8 score on a scale | Standard Deviation 0.88 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 52 | -3.4 score on a scale | Standard Deviation 1.11 |
| Filgotinib 200 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 36 | -3.2 score on a scale | Standard Deviation 1.09 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 36 | -2.9 score on a scale | Standard Deviation 1.17 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline | 5.7 score on a scale | Standard Deviation 0.95 |
| Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 52 | -3.1 score on a scale | Standard Deviation 1.09 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 36 | -2.9 score on a scale | Standard Deviation 1.16 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline | 5.7 score on a scale | Standard Deviation 0.88 |
| Adalimumab | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 52 | -3.1 score on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline | 5.9 score on a scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 52 | -3.3 score on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 36 | -3.3 score on a scale | Standard Deviation 1.1 |
| Placebo to Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 36 | -2.8 score on a scale | Standard Deviation 1.08 |
| Placebo to Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Baseline | 5.6 score on a scale | Standard Deviation 0.89 |
| Placebo to Filgotinib 100 mg | Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 | Change from Baseline at Week 52 | -3.0 score on a scale | Standard Deviation 1.04 |
Secondary
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline | 48 score on a scale | Standard Deviation 22.5 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 52 | 25 score on a scale | Standard Deviation 29.3 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 36 | 21 score on a scale | Standard Deviation 30.6 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 36 | 23 score on a scale | Standard Deviation 28.5 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline | 49 score on a scale | Standard Deviation 22.8 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 52 | 24 score on a scale | Standard Deviation 28.5 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 36 | 20 score on a scale | Standard Deviation 30.9 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline | 47 score on a scale | Standard Deviation 21.8 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 52 | 24 score on a scale | Standard Deviation 29.2 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline | 45 score on a scale | Standard Deviation 21.6 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 52 | 29 score on a scale | Standard Deviation 28.6 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 36 | 28 score on a scale | Standard Deviation 28.2 |
| Placebo to Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 36 | 24 score on a scale | Standard Deviation 26 |
| Placebo to Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Baseline | 47 score on a scale | Standard Deviation 21.1 |
| Placebo to Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 | Change from Baseline at Week 52 | 23 score on a scale | Standard Deviation 29.6 |
Secondary
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 48 score on a scale | Standard Deviation 22.5 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 11 score on a scale | Standard Deviation 24.4 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 18 score on a scale | Standard Deviation 26.3 |
| Filgotinib 200 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 19 score on a scale | Standard Deviation 30.5 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 10 score on a scale | Standard Deviation 25.2 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 17 score on a scale | Standard Deviation 27.4 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 21 score on a scale | Standard Deviation 28.9 |
| Filgotinib 100 mg | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 49 score on a scale | Standard Deviation 22.8 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 17 score on a scale | Standard Deviation 27.1 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 13 score on a scale | Standard Deviation 24.4 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 21 score on a scale | Standard Deviation 28.8 |
| Adalimumab | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 47 score on a scale | Standard Deviation 21.8 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 18 score on a scale | Standard Deviation 29.3 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 10 score on a scale | Standard Deviation 25.1 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Baseline | 46 score on a scale | Standard Deviation 21.8 |
| Placebo | Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 13 score on a scale | Standard Deviation 26.5 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04995% CI: [0, 5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.06995% CI: [0, 5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [4, 9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [4, 9]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.0695% CI: [0, 6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00395% CI: [2, 8]MMRM
Secondary
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline | 27.6 score on a scale | Standard Deviation 10.68 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 11.9 score on a scale | Standard Deviation 10.21 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.0 score on a scale | Standard Deviation 10.22 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.7 score on a scale | Standard Deviation 10.9 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline | 27.8 score on a scale | Standard Deviation 10.6 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 12.2 score on a scale | Standard Deviation 10.88 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.3 score on a scale | Standard Deviation 10.18 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline | 27.2 score on a scale | Standard Deviation 10.2 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 11.7 score on a scale | Standard Deviation 10.79 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline | 26.8 score on a scale | Standard Deviation 10.13 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 12.9 score on a scale | Standard Deviation 11.55 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 12.8 score on a scale | Standard Deviation 10.76 |
| Placebo to Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 9.5 score on a scale | Standard Deviation 10.25 |
| Placebo to Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Baseline | 27.9 score on a scale | Standard Deviation 10.56 |
| Placebo to Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 10.1 score on a scale | Standard Deviation 10.06 |
Secondary
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline; Weeks 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 27.6 score on a scale | Standard Deviation 10.68 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.5 score on a scale | Standard Deviation 10.63 |
| Filgotinib 200 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 6.3 score on a scale | Standard Deviation 8.59 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 27.8 score on a scale | Standard Deviation 10.6 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.8 score on a scale | Standard Deviation 10.77 |
| Filgotinib 100 mg | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 5.7 score on a scale | Standard Deviation 8.77 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 5.7 score on a scale | Standard Deviation 8.47 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 27.2 score on a scale | Standard Deviation 10.2 |
| Adalimumab | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.3 score on a scale | Standard Deviation 9.67 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Baseline | 26.9 score on a scale | Standard Deviation 10.34 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 8.4 score on a scale | Standard Deviation 10.48 |
| Placebo | Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 3.8 score on a scale | Standard Deviation 8.76 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.8, 3.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.2, 3.2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.5, 3.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.6, 3.9]MMRM
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 27.6 score on a scale | Standard Deviation 10.68 |
| Filgotinib 200 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 9.2 score on a scale | Standard Deviation 9.82 |
| Filgotinib 100 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 9.1 score on a scale | Standard Deviation 10.15 |
| Filgotinib 100 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 27.8 score on a scale | Standard Deviation 10.6 |
| Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 27.2 score on a scale | Standard Deviation 10.2 |
| Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 8.8 score on a scale | Standard Deviation 9.19 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline | 26.9 score on a scale | Standard Deviation 10.34 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Change from Baseline at Week 12 | 6.8 score on a scale | Standard Deviation 9.89 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.7, 3.9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.5, 3.7]MMRM
Secondary
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline | 1.59 score on a scale | Standard Deviation 0.611 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 2 | -0.30 score on a scale | Standard Deviation 0.443 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 4 | -0.43 score on a scale | Standard Deviation 0.493 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 24 | -0.82 score on a scale | Standard Deviation 0.632 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 2 | -0.22 score on a scale | Standard Deviation 0.406 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 4 | -0.33 score on a scale | Standard Deviation 0.454 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 24 | -0.75 score on a scale | Standard Deviation 0.597 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline | 1.55 score on a scale | Standard Deviation 0.625 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 4 | -0.40 score on a scale | Standard Deviation 0.46 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 2 | -0.29 score on a scale | Standard Deviation 0.44 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 24 | -0.78 score on a scale | Standard Deviation 0.632 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline | 1.59 score on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 24 | -0.62 score on a scale | Standard Deviation 0.598 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 2 | -0.15 score on a scale | Standard Deviation 0.357 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline | 1.63 score on a scale | Standard Deviation 0.613 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Change from Baseline at Week 4 | -0.26 score on a scale | Standard Deviation 0.431 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.22, -0.12]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.14, -0.04]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.24, -0.13]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.15, -0.04]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.34, -0.19]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.26, -0.11]MMRM
Secondary
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline | 1.59 score on a scale | Standard Deviation 0.611 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 52 | -0.93 score on a scale | Standard Deviation 0.649 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 36 | -0.88 score on a scale | Standard Deviation 0.633 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 36 | -0.80 score on a scale | Standard Deviation 0.611 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline | 1.55 score on a scale | Standard Deviation 0.625 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 52 | -0.85 score on a scale | Standard Deviation 0.621 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 36 | -0.81 score on a scale | Standard Deviation 0.634 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline | 1.59 score on a scale | Standard Deviation 0.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 52 | -0.85 score on a scale | Standard Deviation 0.647 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline | 1.68 score on a scale | Standard Deviation 0.578 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 52 | -0.99 score on a scale | Standard Deviation 0.644 |
| Placebo | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 36 | -0.96 score on a scale | Standard Deviation 0.637 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 36 | -0.69 score on a scale | Standard Deviation 0.61 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline | 1.58 score on a scale | Standard Deviation 0.603 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Change from Baseline at Week 52 | -0.73 score on a scale | Standard Deviation 0.65 |
Secondary
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -11.00 mg/L | Standard Deviation 18.659 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -10.85 mg/L | Standard Deviation 20.154 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -11.84 mg/L | Standard Deviation 20.693 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -9.99 mg/L | Standard Deviation 21.146 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Baseline | 16.13 mg/L | Standard Deviation 21.005 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -8.44 mg/L | Standard Deviation 20.201 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -9.55 mg/L | Standard Deviation 21.33 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -10.54 mg/L | Standard Deviation 22.215 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -7.67 mg/L | Standard Deviation 17.888 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Baseline | 16.74 mg/L | Standard Deviation 22.982 |
| Adalimumab | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -7.17 mg/L | Standard Deviation 16.896 |
| Adalimumab | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Baseline | 14.56 mg/L | Standard Deviation 18.003 |
| Adalimumab | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -8.03 mg/L | Standard Deviation 15.594 |
| Adalimumab | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -7.85 mg/L | Standard Deviation 20.632 |
| Adalimumab | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -6.17 mg/L | Standard Deviation 24.224 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -3.26 mg/L | Standard Deviation 22.711 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -0.07 mg/L | Standard Deviation 17.244 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Baseline | 16.25 mg/L | Standard Deviation 24.051 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -1.12 mg/L | Standard Deviation 19.94 |
| Placebo | Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -4.00 mg/L | Standard Deviation 19.614 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12.7, -8.96]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.58, -5.87]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11.33, -7.45]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.29, -5.42]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.9, -6.13]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.35, -4.58]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9.88, -5.93]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.56, -4.62]MMRM
Secondary
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 36 | -11.51 mg/L | Standard Deviation 21.99 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 52 | -12.19 mg/L | Standard Deviation 20.773 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline | 16.13 mg/L | Standard Deviation 21.005 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 52 | -11.27 mg/L | Standard Deviation 23.129 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline | 16.74 mg/L | Standard Deviation 22.982 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 36 | -10.72 mg/L | Standard Deviation 22.569 |
| Adalimumab | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 36 | -8.73 mg/L | Standard Deviation 18.214 |
| Adalimumab | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline | 14.56 mg/L | Standard Deviation 18.003 |
| Adalimumab | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 52 | -9.60 mg/L | Standard Deviation 16.511 |
| Placebo | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 36 | -12.12 mg/L | Standard Deviation 23.151 |
| Placebo | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline | 16.54 mg/L | Standard Deviation 24.782 |
| Placebo | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 52 | -11.43 mg/L | Standard Deviation 20.873 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 36 | -8.50 mg/L | Standard Deviation 19.749 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Change from Baseline at Week 52 | -8.74 mg/L | Standard Deviation 19.921 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 | Baseline | 15.76 mg/L | Standard Deviation 21.871 |
Secondary
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline | 66 score on a scale | Standard Deviation 16 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -53 score on a scale | Standard Deviation 18.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -51 score on a scale | Standard Deviation 19 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -49 score on a scale | Standard Deviation 19.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline | 65 score on a scale | Standard Deviation 16.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -50 score on a scale | Standard Deviation 19.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -50 score on a scale | Standard Deviation 18.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline | 67 score on a scale | Standard Deviation 15.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -52 score on a scale | Standard Deviation 18.9 |
| Placebo | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline | 68 score on a scale | Standard Deviation 15.6 |
| Placebo | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -54 score on a scale | Standard Deviation 19.7 |
| Placebo | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -53 score on a scale | Standard Deviation 19.5 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -47 score on a scale | Standard Deviation 20 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Baseline | 64 score on a scale | Standard Deviation 16.3 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -50 score on a scale | Standard Deviation 19.3 |
Secondary
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -41 score on a scale | Standard Deviation 20.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -20 score on a scale | Standard Deviation 19.3 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -48 score on a scale | Standard Deviation 19.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -28 score on a scale | Standard Deviation 21.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Baseline | 66 score on a scale | Standard Deviation 16 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -26 score on a scale | Standard Deviation 19.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -39 score on a scale | Standard Deviation 20.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -46 score on a scale | Standard Deviation 19.6 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -18 score on a scale | Standard Deviation 18.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Baseline | 65 score on a scale | Standard Deviation 16.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -26 score on a scale | Standard Deviation 19.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Baseline | 67 score on a scale | Standard Deviation 15.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -19 score on a scale | Standard Deviation 17.9 |
| Adalimumab | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -39 score on a scale | Standard Deviation 20.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -47 score on a scale | Standard Deviation 19.4 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -34 score on a scale | Standard Deviation 22.4 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -13 score on a scale | Standard Deviation 17.8 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Baseline | 66 score on a scale | Standard Deviation 16.2 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -20 score on a scale | Standard Deviation 19.6 |
| Placebo | Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -42 score on a scale | Standard Deviation 20.4 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8, -4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9, -5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-10, -5]MMRM
Secondary
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Baseline | 67 score on a scale | Standard Deviation 19.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -44 score on a scale | Standard Deviation 24.4 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -42 score on a scale | Standard Deviation 24.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -39 score on a scale | Standard Deviation 25.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Baseline | 65 score on a scale | Standard Deviation 19.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -41 score on a scale | Standard Deviation 25.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -39 score on a scale | Standard Deviation 25.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Baseline | 67 score on a scale | Standard Deviation 19.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -42 score on a scale | Standard Deviation 25.7 |
| Placebo | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Baseline | 70 score on a scale | Standard Deviation 17.8 |
| Placebo | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -45 score on a scale | Standard Deviation 27.6 |
| Placebo | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -45 score on a scale | Standard Deviation 24.7 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 36 | -38 score on a scale | Standard Deviation 25.5 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Baseline | 66 score on a scale | Standard Deviation 18.7 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 | Change from Baseline at Week 52 | -41 score on a scale | Standard Deviation 25.3 |
Secondary
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s (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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline | 15 swollen joint count | Standard Deviation 8.5 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 52 | -14 swollen joint count | Standard Deviation 8.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 36 | -14 swollen joint count | Standard Deviation 7.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 36 | -13 swollen joint count | Standard Deviation 7.6 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline | 15 swollen joint count | Standard Deviation 8.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 52 | -13 swollen joint count | Standard Deviation 7.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 36 | -14 swollen joint count | Standard Deviation 7.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline | 16 swollen joint count | Standard Deviation 8.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 52 | -14 swollen joint count | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline | 16 swollen joint count | Standard Deviation 8.2 |
| Placebo | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 52 | -14 swollen joint count | Standard Deviation 7.8 |
| Placebo | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 36 | -14 swollen joint count | Standard Deviation 7.3 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 36 | -13 swollen joint count | Standard Deviation 7.2 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline | 15 swollen joint count | Standard Deviation 7.9 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Change from Baseline at Week 52 | -13 swollen joint count | Standard Deviation 7.4 |
Secondary
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -33 score on a scale | Standard Deviation 24.8 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -16 score on a scale | Standard Deviation 20.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -39 score on a scale | Standard Deviation 25.8 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -22 score on a scale | Standard Deviation 21.5 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Baseline | 67 score on a scale | Standard Deviation 19.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -16 score on a scale | Standard Deviation 20.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -28 score on a scale | Standard Deviation 24.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -36 score on a scale | Standard Deviation 24.9 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -11 score on a scale | Standard Deviation 18.4 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Baseline | 65 score on a scale | Standard Deviation 19.7 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -19 score on a scale | Standard Deviation 20.8 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Baseline | 67 score on a scale | Standard Deviation 19.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -13 score on a scale | Standard Deviation 18.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -28 score on a scale | Standard Deviation 23.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -36 score on a scale | Standard Deviation 24.9 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -21 score on a scale | Standard Deviation 24.8 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -8 score on a scale | Standard Deviation 17.2 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Baseline | 68 score on a scale | Standard Deviation 18.7 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -13 score on a scale | Standard Deviation 20.2 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -31 score on a scale | Standard Deviation 26.9 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7, -2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-16, -10]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-14, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-11, -5]MMRM
Secondary
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -31 score on a scale | Standard Deviation 26.9 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -16 score on a scale | Standard Deviation 21 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -38 score on a scale | Standard Deviation 27 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -21 score on a scale | Standard Deviation 23.7 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Baseline | 65 score on a scale | Standard Deviation 20.4 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -18 score on a scale | Standard Deviation 20.9 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -29 score on a scale | Standard Deviation 25.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -37 score on a scale | Standard Deviation 25.6 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -12 score on a scale | Standard Deviation 18.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Baseline | 64 score on a scale | Standard Deviation 20.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -18 score on a scale | Standard Deviation 21.9 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Baseline | 64 score on a scale | Standard Deviation 19.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -13 score on a scale | Standard Deviation 20.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -27 score on a scale | Standard Deviation 23.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -35 score on a scale | Standard Deviation 24.2 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -21 score on a scale | Standard Deviation 26 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -7 score on a scale | Standard Deviation 18.2 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Baseline | 66 score on a scale | Standard Deviation 19 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -12 score on a scale | Standard Deviation 20.8 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -30 score on a scale | Standard Deviation 27 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8, -3]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-9, -4]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-15, -9]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-13, -7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-14, -7]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-12, -6]MMRM
Secondary
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52
The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Baseline | 65 score on a scale | Standard Deviation 20.4 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 52 | -43 score on a scale | Standard Deviation 26.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 36 | -40 score on a scale | Standard Deviation 26.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 36 | -38 score on a scale | Standard Deviation 26.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Baseline | 64 score on a scale | Standard Deviation 20.1 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 52 | -41 score on a scale | Standard Deviation 25.9 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 36 | -37 score on a scale | Standard Deviation 25.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Baseline | 64 score on a scale | Standard Deviation 19.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 52 | -41 score on a scale | Standard Deviation 25.6 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Baseline | 68 score on a scale | Standard Deviation 18 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 52 | -45 score on a scale | Standard Deviation 26.6 |
| Placebo | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 36 | -44 score on a scale | Standard Deviation 24.9 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 36 | -39 score on a scale | Standard Deviation 25.9 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Baseline | 65 score on a scale | Standard Deviation 19.2 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 | Change from Baseline at Week 52 | -41 score on a scale | Standard Deviation 25.6 |
Secondary
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all 1s (presence of a joint swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -11 swollen joint count | Standard Deviation 7.5 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -6 swollen joint count | Standard Deviation 6.7 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -13 swollen joint count | Standard Deviation 7.8 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -8 swollen joint count | Standard Deviation 7.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline | 15 swollen joint count | Standard Deviation 8.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -8 swollen joint count | Standard Deviation 7.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -11 swollen joint count | Standard Deviation 8.1 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -13 swollen joint count | Standard Deviation 7.4 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -5 swollen joint count | Standard Deviation 6.8 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline | 15 swollen joint count | Standard Deviation 8.5 |
| Adalimumab | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -7 swollen joint count | Standard Deviation 6.6 |
| Adalimumab | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline | 16 swollen joint count | Standard Deviation 8.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -6 swollen joint count | Standard Deviation 5.8 |
| Adalimumab | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -11 swollen joint count | Standard Deviation 7.1 |
| Adalimumab | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -13 swollen joint count | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -10 swollen joint count | Standard Deviation 8.4 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -5 swollen joint count | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline | 16 swollen joint count | Standard Deviation 8.5 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -6 swollen joint count | Standard Deviation 7.8 |
| Placebo | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -12 swollen joint count | Standard Deviation 7.7 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [-2, 0]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04795% CI: [-2, 0]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, -1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-2, -1]MMRM
Secondary
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -17 tender joint count | Standard Deviation 11.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -8 tender joint count | Standard Deviation 10.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -20 tender joint count | Standard Deviation 12.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -11 tender joint count | Standard Deviation 11.1 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline | 25 tender joint count | Standard Deviation 13.5 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -10 tender joint count | Standard Deviation 10.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -15 tender joint count | Standard Deviation 10.7 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -19 tender joint count | Standard Deviation 10.9 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -7 tender joint count | Standard Deviation 9.3 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline | 25 tender joint count | Standard Deviation 13.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -9 tender joint count | Standard Deviation 9.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline | 24 tender joint count | Standard Deviation 13.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -7 tender joint count | Standard Deviation 8.8 |
| Adalimumab | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -15 tender joint count | Standard Deviation 9.9 |
| Adalimumab | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -18 tender joint count | Standard Deviation 11.1 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -13 tender joint count | Standard Deviation 11.6 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -5 tender joint count | Standard Deviation 9 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline | 24 tender joint count | Standard Deviation 13.5 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -8 tender joint count | Standard Deviation 10.5 |
| Placebo | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -17 tender joint count | Standard Deviation 11.7 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.0195% CI: [-3, 0]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-4, -2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-3, -1]MMRM
Secondary
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline | 25 tender joint count | Standard Deviation 13.5 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 52 | -21 tender joint count | Standard Deviation 12.2 |
| Filgotinib 200 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 36 | -21 tender joint count | Standard Deviation 11.9 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 36 | -20 tender joint count | Standard Deviation 11.2 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline | 25 tender joint count | Standard Deviation 13.4 |
| Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 52 | -21 tender joint count | Standard Deviation 11.4 |
| Adalimumab | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 36 | -19 tender joint count | Standard Deviation 11 |
| Adalimumab | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline | 24 tender joint count | Standard Deviation 13.2 |
| Adalimumab | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 52 | -20 tender joint count | Standard Deviation 11.4 |
| Placebo | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline | 25 tender joint count | Standard Deviation 12.8 |
| Placebo | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 52 | -21 tender joint count | Standard Deviation 11.9 |
| Placebo | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 36 | -21 tender joint count | Standard Deviation 11.4 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 36 | -19 tender joint count | Standard Deviation 11.5 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline | 24 tender joint count | Standard Deviation 12.9 |
| Placebo to Filgotinib 100 mg | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Change from Baseline at Week 52 | -20 tender joint count | Standard Deviation 11.2 |
Secondary
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces).
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 32.47 score on a scale | Standard Deviation 47.939 |
| Filgotinib 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Change from Baseline at Week 24 | 0.13 score on a scale | Standard Deviation 0.937 |
| Filgotinib 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Change from Baseline at Week 24 | 0.17 score on a scale | Standard Deviation 0.905 |
| Filgotinib 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 36.70 score on a scale | Standard Deviation 53.065 |
| Adalimumab | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 34.82 score on a scale | Standard Deviation 55.013 |
| Adalimumab | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Change from Baseline at Week 24 | 0.16 score on a scale | Standard Deviation 0.948 |
| Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline | 31.60 score on a scale | Standard Deviation 53.217 |
| Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Change from Baseline at Week 24 | 0.37 score on a scale | Standard Deviation 1.417 |
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.43, -0.12]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00195% CI: [-0.4, -0.1]MMRM
Secondary
Change From Baseline in mTSS at Week 52
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces).
Time frame: Baseline; Week 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in mTSS at Week 52 | Baseline | 32.62 score on a scale | Standard Deviation 48.306 |
| Filgotinib 200 mg | Change From Baseline in mTSS at Week 52 | Change from Baseline at Week 52 | 0.21 score on a scale | Standard Deviation 1.434 |
| Filgotinib 100 mg | Change From Baseline in mTSS at Week 52 | Baseline | 36.24 score on a scale | Standard Deviation 52.956 |
| Filgotinib 100 mg | Change From Baseline in mTSS at Week 52 | Change from Baseline at Week 52 | 0.50 score on a scale | Standard Deviation 2.098 |
| Adalimumab | Change From Baseline in mTSS at Week 52 | Baseline | 33.94 score on a scale | Standard Deviation 53.803 |
| Adalimumab | Change From Baseline in mTSS at Week 52 | Change from Baseline at Week 52 | 0.58 score on a scale | Standard Deviation 3.621 |
| Placebo | Change From Baseline in mTSS at Week 52 | Change from Baseline at Week 52 | 0.63 score on a scale | Standard Deviation 2.782 |
| Placebo | Change From Baseline in mTSS at Week 52 | Baseline | 26.68 score on a scale | Standard Deviation 45.87 |
| Placebo to Filgotinib 100 mg | Change From Baseline in mTSS at Week 52 | Baseline | 32.38 score on a scale | Standard Deviation 55.012 |
| Placebo to Filgotinib 100 mg | Change From Baseline in mTSS at Week 52 | Change from Baseline at Week 52 | 0.90 score on a scale | Standard Deviation 3.152 |
Comparison: LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.04295% CI: [-0.77, -0.01]MMRM
Comparison: LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.03995% CI: [-0.77, -0.02]MMRM
Secondary
Change From Baseline in SDAI at Weeks 36, and 52
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Baseline | 41.2 score on a scale | Standard Deviation 12.26 |
| Filgotinib 200 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -34.1 score on a scale | Standard Deviation 12.15 |
| Filgotinib 200 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -33.3 score on a scale | Standard Deviation 11.92 |
| Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -31.0 score on a scale | Standard Deviation 12.69 |
| Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Baseline | 40.2 score on a scale | Standard Deviation 12.79 |
| Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.0 score on a scale | Standard Deviation 12.25 |
| Adalimumab | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -31.2 score on a scale | Standard Deviation 11.73 |
| Adalimumab | Change From Baseline in SDAI at Weeks 36, and 52 | Baseline | 40.6 score on a scale | Standard Deviation 11.88 |
| Adalimumab | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.6 score on a scale | Standard Deviation 11.99 |
| Placebo | Change From Baseline in SDAI at Weeks 36, and 52 | Baseline | 43.0 score on a scale | Standard Deviation 11.81 |
| Placebo | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -34.9 score on a scale | Standard Deviation 11.83 |
| Placebo | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -35.1 score on a scale | Standard Deviation 11.83 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 36 | -29.9 score on a scale | Standard Deviation 11.4 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Baseline | 39.4 score on a scale | Standard Deviation 11.81 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SDAI at Weeks 36, and 52 | Change from Baseline at Week 52 | -31.6 score on a scale | Standard Deviation 11.11 |
Secondary
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline | 43.9 score on a scale | Standard Deviation 10.44 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 6.7 score on a scale | Standard Deviation 10.53 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 6.2 score on a scale | Standard Deviation 10.03 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 6.6 score on a scale | Standard Deviation 10.46 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline | 44.6 score on a scale | Standard Deviation 10.44 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 6.9 score on a scale | Standard Deviation 10.61 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 6.6 score on a scale | Standard Deviation 9.4 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline | 44.1 score on a scale | Standard Deviation 10.44 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 6.7 score on a scale | Standard Deviation 9.9 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline | 43.9 score on a scale | Standard Deviation 11.06 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 7.2 score on a scale | Standard Deviation 11.31 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 6.9 score on a scale | Standard Deviation 12.05 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 6.8 score on a scale | Standard Deviation 9.84 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Baseline | 43.4 score on a scale | Standard Deviation 11.03 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 6.5 score on a scale | Standard Deviation 10.35 |
Secondary
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 43.9 score on a scale | Standard Deviation 10.44 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 3.9 score on a scale | Standard Deviation 7.96 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 5.4 score on a scale | Standard Deviation 9.45 |
| Filgotinib 200 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 6.1 score on a scale | Standard Deviation 9.23 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 3.4 score on a scale | Standard Deviation 8.35 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 5.4 score on a scale | Standard Deviation 8.97 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 5.7 score on a scale | Standard Deviation 9.57 |
| Filgotinib 100 mg | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 44.6 score on a scale | Standard Deviation 10.44 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 4.9 score on a scale | Standard Deviation 9.69 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 3.7 score on a scale | Standard Deviation 7.66 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 5.3 score on a scale | Standard Deviation 9.25 |
| Adalimumab | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 44.1 score on a scale | Standard Deviation 10.44 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | 5.6 score on a scale | Standard Deviation 10.28 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | 2.3 score on a scale | Standard Deviation 8.72 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Baseline | 43.4 score on a scale | Standard Deviation 11.01 |
| Placebo | Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | 4.1 score on a scale | Standard Deviation 9.5 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [0.9, 2.8]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00295% CI: [0.6, 2.5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00695% CI: [0.4, 2.5]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.00195% CI: [0.7, 2.7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.08695% CI: [-0.1, 2]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: 0.1295% CI: [-0.2, 1.9]MMRM
Secondary
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline | 33.4 score on a scale | Standard Deviation 7.17 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 12.0 score on a scale | Standard Deviation 8.73 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.6 score on a scale | Standard Deviation 8.28 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.0 score on a scale | Standard Deviation 8.53 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline | 33.6 score on a scale | Standard Deviation 7.75 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 11.5 score on a scale | Standard Deviation 8.74 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 11.1 score on a scale | Standard Deviation 9.07 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline | 32.8 score on a scale | Standard Deviation 7.74 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 12.4 score on a scale | Standard Deviation 9.21 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline | 32.2 score on a scale | Standard Deviation 6.96 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 13.0 score on a scale | Standard Deviation 9.58 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 12.9 score on a scale | Standard Deviation 8.92 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 36 | 9.5 score on a scale | Standard Deviation 8.13 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Baseline | 33.7 score on a scale | Standard Deviation 6.96 |
| Placebo to Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 | Change from Baseline at Week 52 | 10.4 score on a scale | Standard Deviation 8.05 |
Secondary
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time frame: Baseline; Weeks 4, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 33.4 score on a scale | Standard Deviation 7.17 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.4 score on a scale | Standard Deviation 8.49 |
| Filgotinib 200 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 5.6 score on a scale | Standard Deviation 6.57 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 33.6 score on a scale | Standard Deviation 7.75 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.3 score on a scale | Standard Deviation 8.64 |
| Filgotinib 100 mg | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 4.6 score on a scale | Standard Deviation 6.5 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 5.0 score on a scale | Standard Deviation 6.65 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 32.8 score on a scale | Standard Deviation 7.74 |
| Adalimumab | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 10.4 score on a scale | Standard Deviation 8.47 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Baseline | 32.9 score on a scale | Standard Deviation 7.11 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 24 | 7.7 score on a scale | Standard Deviation 7.97 |
| Placebo | Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 | Change from Baseline at Week 4 | 3.1 score on a scale | Standard Deviation 6.32 |
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1.9, 3.4]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [1, 2.5]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2.1, 4.1]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [2, 4.1]MMRM
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -27.1 score on a scale | Standard Deviation 12.69 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -14.0 score on a scale | Standard Deviation 12.19 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -31.8 score on a scale | Standard Deviation 12.18 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -18.6 score on a scale | Standard Deviation 13.08 |
| Filgotinib 200 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Baseline | 41.2 score on a scale | Standard Deviation 12.26 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -16.4 score on a scale | Standard Deviation 12.31 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -24.1 score on a scale | Standard Deviation 12.54 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -29.7 score on a scale | Standard Deviation 12.01 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -11.4 score on a scale | Standard Deviation 11.41 |
| Filgotinib 100 mg | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Baseline | 40.2 score on a scale | Standard Deviation 12.79 |
| Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -16.1 score on a scale | Standard Deviation 11.47 |
| Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Baseline | 40.6 score on a scale | Standard Deviation 11.88 |
| Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -12.5 score on a scale | Standard Deviation 10.52 |
| Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -24.3 score on a scale | Standard Deviation 12.03 |
| Adalimumab | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -29.0 score on a scale | Standard Deviation 12.19 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 12 | -20.6 score on a scale | Standard Deviation 13.85 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 2 | -8.2 score on a scale | Standard Deviation 10.38 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Baseline | 41.2 score on a scale | Standard Deviation 12.37 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 4 | -12.5 score on a scale | Standard Deviation 12.18 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 | Change from Baseline at Week 24 | -26.6 score on a scale | Standard Deviation 12.91 |
Comparison: Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.1, -4.4]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-5, -2.2]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.6, -4.6]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6, -3.1]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-8.2, -5.4]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.5, -3.7]MMRM
Comparison: Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-7.8, -5.3]MMRM
Comparison: Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-6.1, -3.5]MMRM
Secondary
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (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). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.59 score on a scale | Standard Deviation 0.611 |
| Filgotinib 200 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.69 score on a scale | Standard Deviation 0.613 |
| Filgotinib 100 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.56 score on a scale | Standard Deviation 0.564 |
| Filgotinib 100 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.55 score on a scale | Standard Deviation 0.625 |
| Adalimumab | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.59 score on a scale | Standard Deviation 0.6 |
| Adalimumab | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.61 score on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline | 1.63 score on a scale | Standard Deviation 0.613 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Change from Baseline at Week 12 | -0.42 score on a scale | Standard Deviation 0.544 |
Comparison: Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.36, -0.22]Mixed effects model for repeated measure
Comparison: Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.p-value: <0.00195% CI: [-0.24, -0.1]MMRM
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline | 61.5 percentage of activity impairment | Standard Deviation 22.74 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -34.8 percentage of activity impairment | Standard Deviation 26.74 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -32.6 percentage of activity impairment | Standard Deviation 26.66 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -31.5 percentage of activity impairment | Standard Deviation 25.66 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline | 60.5 percentage of activity impairment | Standard Deviation 23.85 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -33.7 percentage of activity impairment | Standard Deviation 26.44 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -30.2 percentage of activity impairment | Standard Deviation 26.93 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline | 61.3 percentage of activity impairment | Standard Deviation 21.2 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.9 percentage of activity impairment | Standard Deviation 26.03 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline | 62.9 percentage of activity impairment | Standard Deviation 21.74 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -35.2 percentage of activity impairment | Standard Deviation 28 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -34.9 percentage of activity impairment | Standard Deviation 26.6 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -27.5 percentage of activity impairment | Standard Deviation 26.14 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Baseline | 59.7 percentage of activity impairment | Standard Deviation 22.1 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -30.8 percentage of activity impairment | Standard Deviation 25.99 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 61.5 percentage of activity impairment | Standard Deviation 22.74 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -17.0 percentage of activity impairment | Standard Deviation 22.46 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -26.5 percentage of activity impairment | Standard Deviation 25.17 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -30.7 percentage of activity impairment | Standard Deviation 26.2 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -14.7 percentage of activity impairment | Standard Deviation 22.07 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -24.1 percentage of activity impairment | Standard Deviation 24.95 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -30.4 percentage of activity impairment | Standard Deviation 25.45 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 60.5 percentage of activity impairment | Standard Deviation 23.85 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -22.6 percentage of activity impairment | Standard Deviation 24.93 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -14.8 percentage of activity impairment | Standard Deviation 23.36 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -28.6 percentage of activity impairment | Standard Deviation 24.99 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 61.3 percentage of activity impairment | Standard Deviation 21.2 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -21.9 percentage of activity impairment | Standard Deviation 27.78 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -9.8 percentage of activity impairment | Standard Deviation 20.98 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 62.2 percentage of activity impairment | Standard Deviation 22.11 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -16.9 percentage of activity impairment | Standard Deviation 25.98 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline | 49.1 percentage of impairment while working | Standard Deviation 25.23 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -31.7 percentage of impairment while working | Standard Deviation 27.44 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -29.7 percentage of impairment while working | Standard Deviation 26.73 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -27.5 percentage of impairment while working | Standard Deviation 26.28 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline | 48.0 percentage of impairment while working | Standard Deviation 24.61 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -29.5 percentage of impairment while working | Standard Deviation 24.66 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -27.8 percentage of impairment while working | Standard Deviation 29.9 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline | 50.8 percentage of impairment while working | Standard Deviation 22.98 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -29.4 percentage of impairment while working | Standard Deviation 27.91 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline | 53.8 percentage of impairment while working | Standard Deviation 26.35 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -30.6 percentage of impairment while working | Standard Deviation 28.24 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -32.0 percentage of impairment while working | Standard Deviation 26.82 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -26.4 percentage of impairment while working | Standard Deviation 29.86 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Baseline | 53.6 percentage of impairment while working | Standard Deviation 23.4 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.5 percentage of impairment while working | Standard Deviation 28.17 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 49.1 percentage of impairment while working | Standard Deviation 25.23 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -15.1 percentage of impairment while working | Standard Deviation 23.19 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -24.1 percentage of impairment while working | Standard Deviation 25.83 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -27.4 percentage of impairment while working | Standard Deviation 26.37 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -10.2 percentage of impairment while working | Standard Deviation 22.82 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -21.9 percentage of impairment while working | Standard Deviation 23.22 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -25.9 percentage of impairment while working | Standard Deviation 26.59 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 48.0 percentage of impairment while working | Standard Deviation 24.61 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -22.9 percentage of impairment while working | Standard Deviation 24.88 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -15.3 percentage of impairment while working | Standard Deviation 24.84 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -23.3 percentage of impairment while working | Standard Deviation 27.56 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 50.8 percentage of impairment while working | Standard Deviation 22.98 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -21.2 percentage of impairment while working | Standard Deviation 29.33 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -9.5 percentage of impairment while working | Standard Deviation 23.68 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Baseline | 52.5 percentage of impairment while working | Standard Deviation 25.89 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -17.1 percentage of impairment while working | Standard Deviation 27.24 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline | 51.3 percentage of work productivity loss | Standard Deviation 25.95 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -31.6 percentage of work productivity loss | Standard Deviation 29.17 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -28.9 percentage of work productivity loss | Standard Deviation 27.16 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -25.7 percentage of work productivity loss | Standard Deviation 29.54 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline | 50.6 percentage of work productivity loss | Standard Deviation 25.87 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -28.4 percentage of work productivity loss | Standard Deviation 27.11 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -28.6 percentage of work productivity loss | Standard Deviation 31.48 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline | 54.3 percentage of work productivity loss | Standard Deviation 24.85 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -29.3 percentage of work productivity loss | Standard Deviation 29.38 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline | 56.6 percentage of work productivity loss | Standard Deviation 27.36 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -30.3 percentage of work productivity loss | Standard Deviation 30.73 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -31.7 percentage of work productivity loss | Standard Deviation 30.53 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 36 | -26.9 percentage of work productivity loss | Standard Deviation 31.02 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Baseline | 57.1 percentage of work productivity loss | Standard Deviation 25.14 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Change from Baseline at Week 52 | -32.7 percentage of work productivity loss | Standard Deviation 29.65 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 51.3 percentage of work productivity loss | Standard Deviation 25.95 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -14.6 percentage of work productivity loss | Standard Deviation 24.59 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -23.2 percentage of work productivity loss | Standard Deviation 28.18 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -27.1 percentage of work productivity loss | Standard Deviation 27.78 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -10.2 percentage of work productivity loss | Standard Deviation 23.71 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -22.3 percentage of work productivity loss | Standard Deviation 24.34 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -26.3 percentage of work productivity loss | Standard Deviation 27.29 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 50.6 percentage of work productivity loss | Standard Deviation 25.87 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -22.8 percentage of work productivity loss | Standard Deviation 26.61 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -16.8 percentage of work productivity loss | Standard Deviation 26.29 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -23.6 percentage of work productivity loss | Standard Deviation 29.4 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 54.3 percentage of work productivity loss | Standard Deviation 24.85 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -19.3 percentage of work productivity loss | Standard Deviation 30.81 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -10.0 percentage of work productivity loss | Standard Deviation 24.06 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Baseline | 55.8 percentage of work productivity loss | Standard Deviation 27.33 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -17.5 percentage of work productivity loss | Standard Deviation 28.09 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline | 12.0 percentage of work time missed | Standard Deviation 25.77 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -6.8 percentage of work time missed | Standard Deviation 26.27 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -4.4 percentage of work time missed | Standard Deviation 24.04 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -1.5 percentage of work time missed | Standard Deviation 24.41 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline | 9.9 percentage of work time missed | Standard Deviation 20.91 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -1.7 percentage of work time missed | Standard Deviation 21.89 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -8.7 percentage of work time missed | Standard Deviation 27.43 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline | 16.0 percentage of work time missed | Standard Deviation 27.57 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -7.1 percentage of work time missed | Standard Deviation 24 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline | 18.3 percentage of work time missed | Standard Deviation 31.61 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -7.4 percentage of work time missed | Standard Deviation 26.76 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -6.2 percentage of work time missed | Standard Deviation 30.25 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 36 | -7.5 percentage of work time missed | Standard Deviation 25 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Baseline | 14.6 percentage of work time missed | Standard Deviation 26.88 |
| Placebo to Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Change from Baseline at Week 52 | -8.9 percentage of work time missed | Standard Deviation 27.9 |
Secondary
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline; Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 12.0 percentage of work time missed | Standard Deviation 25.77 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -1.4 percentage of work time missed | Standard Deviation 21.24 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -4.3 percentage of work time missed | Standard Deviation 22.55 |
| Filgotinib 200 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -6.1 percentage of work time missed | Standard Deviation 24.77 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -2.1 percentage of work time missed | Standard Deviation 18.14 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -3.8 percentage of work time missed | Standard Deviation 18.37 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -3.8 percentage of work time missed | Standard Deviation 16.92 |
| Filgotinib 100 mg | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 9.9 percentage of work time missed | Standard Deviation 20.91 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -7.5 percentage of work time missed | Standard Deviation 28.79 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -7.5 percentage of work time missed | Standard Deviation 24.26 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -9.3 percentage of work time missed | Standard Deviation 28.99 |
| Adalimumab | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 16.0 percentage of work time missed | Standard Deviation 27.57 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 24 | -1.5 percentage of work time missed | Standard Deviation 27.24 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 4 | -5.7 percentage of work time missed | Standard Deviation 25.65 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Baseline | 17.0 percentage of work time missed | Standard Deviation 29.52 |
| Placebo | Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Change from Baseline at Week 12 | -5.9 percentage of work time missed | Standard Deviation 27.94 |
Secondary
EQ-5D Current Health VAS at Weeks 36, and 52
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 36 | 69 score on a scale | Standard Deviation 22.7 |
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 52 | 72 score on a scale | Standard Deviation 21.3 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 36 | 72 score on a scale | Standard Deviation 21.2 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 52 | 73 score on a scale | Standard Deviation 21 |
| Adalimumab | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 36 | 67 score on a scale | Standard Deviation 24.3 |
| Adalimumab | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 52 | 71 score on a scale | Standard Deviation 22.5 |
| Placebo | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 52 | 73 score on a scale | Standard Deviation 20.6 |
| Placebo | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 36 | 73 score on a scale | Standard Deviation 19.9 |
| Placebo to Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 36 | 71 score on a scale | Standard Deviation 21.1 |
| Placebo to Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 36, and 52 | Week 52 | 70 score on a scale | Standard Deviation 22.8 |
Secondary
EQ-5D Current Health VAS at Weeks 4, 12, and 24
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 59 score on a scale | Standard Deviation 20.5 |
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 67 score on a scale | Standard Deviation 23.1 |
| Filgotinib 200 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 66 score on a scale | Standard Deviation 20.3 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 59 score on a scale | Standard Deviation 19.9 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 69 score on a scale | Standard Deviation 21.6 |
| Filgotinib 100 mg | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 66 score on a scale | Standard Deviation 20.3 |
| Adalimumab | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 65 score on a scale | Standard Deviation 19.6 |
| Adalimumab | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 60 score on a scale | Standard Deviation 20.4 |
| Adalimumab | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 68 score on a scale | Standard Deviation 22.2 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 4 | 56 score on a scale | Standard Deviation 19.5 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 24 | 64 score on a scale | Standard Deviation 21.4 |
| Placebo | EQ-5D Current Health VAS at Weeks 4, 12, and 24 | Week 12 | 59 score on a scale | Standard Deviation 20.7 |
Secondary
FACIT-Fatigue Score at Weeks 36, and 52
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 36 | 38.9 score on a scale | Standard Deviation 8.84 |
| Filgotinib 200 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 52 | 39.8 score on a scale | Standard Deviation 8.64 |
| Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 36 | 39.5 score on a scale | Standard Deviation 8.73 |
| Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 52 | 39.8 score on a scale | Standard Deviation 8.54 |
| Adalimumab | FACIT-Fatigue Score at Weeks 36, and 52 | Week 36 | 38.6 score on a scale | Standard Deviation 9.45 |
| Adalimumab | FACIT-Fatigue Score at Weeks 36, and 52 | Week 52 | 38.9 score on a scale | Standard Deviation 9.87 |
| Placebo | FACIT-Fatigue Score at Weeks 36, and 52 | Week 52 | 39.4 score on a scale | Standard Deviation 8.78 |
| Placebo | FACIT-Fatigue Score at Weeks 36, and 52 | Week 36 | 39.6 score on a scale | Standard Deviation 8.78 |
| Placebo to Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 36 | 37.4 score on a scale | Standard Deviation 9.88 |
| Placebo to Filgotinib 100 mg | FACIT-Fatigue Score at Weeks 36, and 52 | Week 52 | 38.0 score on a scale | Standard Deviation 9.77 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 33.9 score on a scale | Standard Deviation 10.32 |
| Filgotinib 200 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 38.5 score on a scale | Standard Deviation 9.17 |
| Filgotinib 200 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 36.8 score on a scale | Standard Deviation 9.64 |
| Filgotinib 100 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 33.3 score on a scale | Standard Deviation 9.76 |
| Filgotinib 100 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 38.5 score on a scale | Standard Deviation 8.74 |
| Filgotinib 100 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 36.7 score on a scale | Standard Deviation 9.67 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 36.1 score on a scale | Standard Deviation 9.68 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 32.9 score on a scale | Standard Deviation 10.11 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 37.6 score on a scale | Standard Deviation 9.82 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 4 | 30.9 score on a scale | Standard Deviation 10.43 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 24 | 35.8 score on a scale | Standard Deviation 9.94 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 | Week 12 | 33.9 score on a scale | Standard Deviation 10.32 |
Secondary
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | No Problems | 254 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Moderate Problems | 58 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Moderate Problems | 30 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Slight Problems | 104 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Slight Problems | 98 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | No Problems | 251 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Moderate Problems | 31 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 37 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 123 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Severe Problems | 13 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 48 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 230 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 10 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Slight Problems | 121 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 77 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 209 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 90 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | No Problems | 197 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 13 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 81 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Slight Problems | 117 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | No Problems | 202 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 206 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 95 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Moderate Problems | 57 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 106 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Severe Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 40 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Slight Problems | 151 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Severe Problems | 11 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 227 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | No Problems | 183 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Severe Problems | 7 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 50 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Slight Problems | 160 Participants |
| Filgotinib 200 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | No Problems | 176 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Slight Problems | 115 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | No Problems | 189 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Slight Problems | 136 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Moderate Problems | 64 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Severe Problems | 15 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | No Problems | 187 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Moderate Problems | 58 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Severe Problems | 19 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | No Problems | 249 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Slight Problems | 113 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Moderate Problems | 36 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | No Problems | 245 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Slight Problems | 102 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Moderate Problems | 25 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Severe Problems | 6 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | No Problems | 172 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Slight Problems | 171 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 52 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Severe Problems | 9 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | No Problems | 177 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Slight Problems | 147 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 41 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Severe Problems | 12 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 84 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 220 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 89 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 11 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 88 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 210 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 72 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 9 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 259 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 113 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 27 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 5 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 254 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 86 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 34 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 5 Participants |
| Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Severe Problems | 7 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Slight Problems | 82 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 55 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Severe Problems | 2 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Slight Problems | 79 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 9 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 127 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Slight Problems | 67 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 61 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 23 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 61 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 79 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Slight Problems | 90 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Extreme Problems | 2 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | No Problems | 159 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 2 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 8 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 130 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | No Problems | 130 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Moderate Problems | 48 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 57 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Severe Problems | 10 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Moderate Problems | 24 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | No Problems | 121 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Extreme Problems | 3 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Severe Problems | 6 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | No Problems | 122 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Slight Problems | 87 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 3 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Moderate Problems | 30 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 46 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 169 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 42 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | No Problems | 164 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 19 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Moderate Problems | 38 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 7 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Severe Problems | 6 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Slight Problems | 72 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 4 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 79 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 162 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | No Problems | 125 Participants |
| Adalimumab | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Severe Problems | 16 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Moderate Problems | 17 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | No Problems | 82 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Slight Problems | 71 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 21 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Severe Problems | 3 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Severe Problems | 3 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Slight Problems | 58 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | No Problems | 75 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Slight Problems | 64 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Moderate Problems | 34 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 22 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 111 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Severe Problems | 5 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Slight Problems | 47 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 47 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 94 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 34 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | No Problems | 82 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 38 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 2 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 45 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 80 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 38 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 17 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 3 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Severe Problems | 7 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | No Problems | 86 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 115 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 44 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Moderate Problems | 26 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 18 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Severe Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Slight Problems | 45 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | No Problems | 105 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Slight Problems | 44 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Moderate Problems | 16 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | No Problems | 114 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 0 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Severe Problems | 1 Participants |
| Placebo | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Extreme Problems | 1 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Severe Problems | 6 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | No Problems | 110 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Slight Problems | 48 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | No Problems | 112 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Moderate Problems | 28 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | No Problems | 108 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Slight Problems | 61 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Moderate Problems | 36 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Slight Problems | 51 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Slight Problems | 70 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Severe Problems | 12 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Moderate Problems | 19 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Extreme Problems | 1 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Moderate Problems | 25 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | Slight Problems | 72 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | No Problems | 72 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Moderate Problems | 27 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Moderate Problems | 18 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Severe Problems | 5 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Slight Problems | 46 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Moderate Problems | 16 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 52 | No Problems | 71 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Severe Problems | 5 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 36 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | No Problems | 78 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Slight Problems | 67 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | No Problems | 44 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Extreme Problems | 1 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Slight Problems | 41 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Severe Problems | 7 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 36 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Slight Problems | 93 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Moderate Problems | 45 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | No Problems | 77 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | Slight Problems | 97 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Severe Problems | 4 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Moderate Problems | 31 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 36 | Severe Problems | 11 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | No Problems | 101 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Extreme Problems | 0 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Usual Activities: Week 36 | Severe Problems | 5 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Severe Problems | 6 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Self-care: Week 52 | Extreme Problems | 1 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Anxiety/Depression: Week 52 | Moderate Problems | 19 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 36 | No Problems | 35 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Mobility: Week 52 | Severe Problems | 8 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 | Pain/Discomfort: Week 52 | Extreme Problems | 0 Participants |
Secondary
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 21 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 113 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 110 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 21 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 44 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 230 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 51 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 203 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 80 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 109 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 178 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 6 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 82 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 154 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 153 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 111 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 53 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 99 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 16 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 215 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 21 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 38 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 86 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 45 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 136 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 42 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | No Problems | 182 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 235 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 260 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Slight Problems | 142 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 42 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 149 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Moderate Problems | 68 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 226 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 211 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 200 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Severe Problems | 19 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 13 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Extreme Problems | 5 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 4 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 154 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 72 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 177 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 58 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 0 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 54 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 180 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 12 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 163 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 20 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 86 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 130 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 3 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 164 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 23 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 255 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 54 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 6 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 2 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 176 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 117 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 184 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 243 Participants |
| Filgotinib 200 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 157 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 222 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 4 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 150 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 74 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 23 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 9 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 5 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 224 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 90 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 249 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 150 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 121 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 191 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 39 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 8 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 149 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 102 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 193 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 256 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 142 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 158 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 33 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 217 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 119 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 37 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 71 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 5 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 81 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 3 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 129 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 173 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 78 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 122 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 41 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 46 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 8 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 13 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 204 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 177 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 151 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 185 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 97 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 0 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 31 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 38 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | No Problems | 189 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 1 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Slight Problems | 136 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 246 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Moderate Problems | 75 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 9 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Severe Problems | 17 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 63 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 163 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 143 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 183 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 224 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 171 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 103 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 17 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 20 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 175 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 2 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 63 Participants |
| Filgotinib 100 mg | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 103 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 47 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 12 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 151 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 111 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 44 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 13 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 152 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 106 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 44 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 4 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 160 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 75 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 33 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 6 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 3 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 84 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 107 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 96 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 31 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 116 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 103 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 67 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 21 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | No Problems | 117 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Slight Problems | 90 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Moderate Problems | 57 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Severe Problems | 12 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 111 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 120 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 74 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 13 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 147 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 102 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 49 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 9 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 157 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 75 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 36 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 7 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 2 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 69 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 133 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 90 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 25 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 2 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 97 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 130 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 67 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 13 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 109 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 105 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 52 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 9 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 2 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 26 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 118 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 127 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 1 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 34 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 145 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 106 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 22 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 0 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 56 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 127 Participants |
| Adalimumab | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 82 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | No Problems | 165 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Slight Problems | 196 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Extreme Problems | 6 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Severe Problems | 25 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Severe Problems | 51 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | No Problems | 107 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Moderate Problems | 124 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | Slight Problems | 164 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | No Problems | 216 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Slight Problems | 163 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 4 | No Problems | 138 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Moderate Problems | 86 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Severe Problems | 24 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Moderate Problems | 89 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Severe Problems | 15 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | Slight Problems | 126 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: week 24 | No Problems | 131 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Extreme Problems | 3 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 24 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Severe Problems | 38 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Severe Problems | 25 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | No Problems | 14 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Moderate Problems | 112 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | Slight Problems | 154 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Moderate Problems | 86 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Slight Problems | 157 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 12 | No Problems | 132 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Severe Problems | 27 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Moderate Problems | 198 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Severe Problems | 56 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Moderate Problems | 150 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | Slight Problems | 149 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Severe Problems | 80 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Mobility: Week 4 | No Problems | 100 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Extreme Problems | 1 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | No Problems | 39 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 4 | Extreme Problems | 8 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Severe Problems | 8 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Moderate Problems | 39 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | Slight Problems | 149 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | No Problems | 29 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | Slight Problems | 120 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 24 | No Problems | 204 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 4 | No Problems | 196 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Slight Problems | 200 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Moderate Problems | 143 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Extreme Problems | 3 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Severe Problems | 52 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Slight Problems | 195 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | No Problems | 65 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Severe Problems | 19 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 4 | Extreme Problems | 2 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Extreme Problems | 0 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Severe Problems | 14 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 24 | Moderate Problems | 110 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | No Problems | 103 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Moderate Problems | 54 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | Slight Problems | 140 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Pain/Discomfort: Week 12 | Moderate Problems | 154 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Slight Problems | 184 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 24 | No Problems | 164 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Extreme Problems | 4 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Moderate Problems | 62 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Moderate Problems | 116 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Severe Problems | 21 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Moderate Problems | 88 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Anxiety/Depression: Week 12 | Slight Problems | 137 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Usual Activities: Week 12 | Severe Problems | 32 Participants |
| Placebo | Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 | Self-care: Week 12 | Slight Problems | 159 Participants |
Secondary
Number of Participants With EULAR Response at Weeks 36, and 52
Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>0.6 and ≤1.2; DAS28(CRP) at visit \>3.2 and ≤5.1 and improvement from baseline \>0.6; DAS 28(CRP) at visit \>5.1 and improvement from baseline \>1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) \>5.1 at visit and improvement from baseline ≤1.2.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Moderate Response | 99 Participants |
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Good Response | 306 Participants |
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | No Response | 2 Participants |
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Good Response | 308 Participants |
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Moderate Response | 82 Participants |
| Filgotinib 200 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | No Response | 3 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Moderate Response | 98 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | No Response | 5 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Good Response | 276 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | No Response | 11 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Good Response | 282 Participants |
| Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Moderate Response | 126 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Good Response | 189 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Moderate Response | 66 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Good Response | 180 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | No Response | 8 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Moderate Response | 84 Participants |
| Adalimumab | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | No Response | 4 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Good Response | 129 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Moderate Response | 38 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | No Response | 0 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | No Response | 2 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Moderate Response | 38 Participants |
| Placebo | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Good Response | 139 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Moderate Response | 42 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | No Response | 3 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | No Response | 6 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Moderate Response | 54 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 52 | Good Response | 126 Participants |
| Placebo to Filgotinib 100 mg | Number of Participants With EULAR Response at Weeks 36, and 52 | Week 36 | Good Response | 124 Participants |
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline \>0.6 and ≤1.2; DAS28(CRP) at visit \>3.2 and ≤5.1 and improvement from baseline \>0.6; DAS 28(CRP) at visit \>5.1 and improvement from baseline \>1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) \>5.1 at visit and improvement from baseline ≤1.2.
Time frame: Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Good Response | 284 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | No Response | 7 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Moderate Response | 188 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Good Response | 58 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | No Response | 33 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | No Response | 157 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Good Response | 117 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Moderate Response | 237 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Moderate Response | 124 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Moderate Response | 231 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | No Response | 115 Participants |
| Filgotinib 200 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Good Response | 234 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Moderate Response | 213 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Good Response | 177 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Good Response | 86 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | No Response | 50 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Good Response | 250 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Moderate Response | 225 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Good Response | 32 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | No Response | 139 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Moderate Response | 242 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | No Response | 219 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | No Response | 13 Participants |
| Filgotinib 100 mg | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Moderate Response | 156 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Moderate Response | 138 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Good Response | 27 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Moderate Response | 158 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | No Response | 129 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Good Response | 61 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Moderate Response | 156 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | No Response | 101 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Good Response | 138 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | No Response | 32 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Good Response | 163 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Moderate Response | 97 Participants |
| Adalimumab | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | No Response | 21 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | No Response | 228 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Moderate Response | 189 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Good Response | 15 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Good Response | 154 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 4 | Good Response | 37 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | No Response | 313 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | No Response | 44 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 24 | Moderate Response | 170 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Moderate Response | 224 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | Good Response | 106 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 2 | Moderate Response | 133 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 | Week 12 | No Response | 101 Participants |
Secondary
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 2 | 37.3 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 24 | 78.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 4 | 51.6 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 2 | 27.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 24 | 77.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 4 | 45.6 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 4 | 47.1 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 2 | 33.5 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 24 | 74.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 2 | 14.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 24 | 59.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Week 4 | 31.8 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2p-value: <0.00195% CI: [16.7, 27.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2p-value: <0.00195% CI: [7.2, 17.9]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [13.4, 26.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: <0.00195% CI: [7.5, 20.2]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [13, 24.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: <0.00195% CI: [12.6, 24.5]Regression, Logistic
Secondary
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 36 | 82.9 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 52 | 82.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 36 | 79.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 52 | 79.6 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 36 | 76.3 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 52 | 77.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 52 | 86.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 36 | 90.5 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 36 | 86.9 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Week 52 | 85.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 36 | 63.2 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 52 | 64.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 36 | 57.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 52 | 60.6 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 36 | 57.5 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 52 | 62.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 52 | 68.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 36 | 67.9 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 36 | 63.4 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Week 52 | 66.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 4 | 22.3 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 24 | 57.9 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 2 | 9.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 12 | 47.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 24 | 52.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 12 | 36.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 4 | 12.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 2 | 5.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 12 | 35.1 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 24 | 52.3 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 4 | 17.2 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 2 | 6.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 12 | 19.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 2 | 1.1 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 24 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Week 4 | 5.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2p-value: <0.00195% CI: [5.1, 10.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2p-value: <0.00195% CI: [2.3, 7.3]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [11.9, 20.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: <0.00195% CI: [3.1, 10.9]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [21.4, 33.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [10.9, 22.5]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [18.3, 31]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: <0.00195% CI: [13.1, 25.8]Regression, Logistic
Secondary
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 36 | 40.2 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 52 | 44.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 36 | 35.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 52 | 39.0 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 36 | 32.9 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 52 | 41.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 52 | 48.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 36 | 44.7 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 36 | 34.6 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Week 52 | 37.7 percentage of participants |
Secondary
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 2 | 2.7 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 4 | 9.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 12 | 26.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 24 | 36.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 4 | 3.3 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 12 | 18.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 24 | 29.6 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 2 | 1.3 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 12 | 14.2 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 4 | 3.7 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 24 | 29.5 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 2 | 0.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 24 | 14.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 4 | 1.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 2 | 0.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Week 12 | 6.7 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2p-value: 0.00895% CI: [0.5, 4.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2p-value: 0.1895% CI: [-0.5, 2.2]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [4.6, 10.6]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: 0.06795% CI: [-0.3, 4]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [14.6, 24.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [7.5, 16.2]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [15.7, 26.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: <0.00195% CI: [9.2, 20]Regression, Logistic
Secondary
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 2 | 52.5 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 4 | 66.2 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 12 | 78.9 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 24 | 76.0 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 4 | 58.0 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 12 | 71.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 24 | 73.4 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 2 | 46.7 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 12 | 72.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 4 | 63.9 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 24 | 71.2 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 2 | 51.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 24 | 59.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 4 | 49.9 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 2 | 40.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 | Week 12 | 57.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2.p-value: <0.00195% CI: [5.7, 18.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2.p-value: 0.04395% CI: [-0.1, 13.1]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4.p-value: <0.00195% CI: [9.8, 22.8]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4.p-value: 0.01195% CI: [1.5, 14.7]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12.p-value: <0.00195% CI: [14.9, 27]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12.p-value: <0.00195% CI: [7.3, 19.9]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24.p-value: <0.00195% CI: [10.5, 22.8]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24.p-value: <0.00195% CI: [7.8, 20.3]Regression, Logistic
Secondary
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 36 | 77.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 52 | 75.8 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 36 | 74.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 52 | 73.0 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 36 | 71.5 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 52 | 70.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 52 | 81.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 36 | 83.2 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 36 | 77.7 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 | Week 52 | 71.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 2 | 5.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 24 | 48.4 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 4 | 13.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 2 | 1.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 24 | 35.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 4 | 8.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 4 | 8.0 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 2 | 3.4 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 24 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 2 | 0.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 24 | 16.2 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 | Week 4 | 2.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2.p-value: <0.00195% CI: [2.1, 6.7]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2.p-value: 0.1795% CI: [-0.5, 2.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4.p-value: <0.00195% CI: [7.1, 14.4]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4.p-value: <0.00195% CI: [2.6, 9]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24.p-value: <0.00195% CI: [26.4, 38]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24.p-value: <0.00195% CI: [13.4, 24.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Adalimumab at Week 24.p-value: <0.00195% CI: [5.6, 19.9]Regression, Logistic
Comparison: Filgotinib 100 mg vs Adalimumab at Week 24.p-value: 0.8895% CI: [-7.5, 6.5]Regression, Logistic
Comparison: Filgotinib 200 mg vs Adalimumab at Week 24.p-value: <0.001Method proposed by [Liu 2014]
Comparison: Filgotinib 100 mg vs Adalimumab at Week 24.p-value: <0.001Method proposed by [Liu 2014]
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 36, and 52
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 36 | 50.3 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 52 | 54.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 36 | 42.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 52 | 44.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 36 | 42.5 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 52 | 48.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 52 | 50.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 36 | 52.1 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 36 | 46.1 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 | Week 52 | 50.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | 49.7 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | 38.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | 43.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | 23.4 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 12p-value: <0.00195% CI: [20.2, 32.4]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12p-value: <0.00195% CI: [9.4, 21.4]Regression, Logistic
Comparison: Filgotinib 200 mg vs Adalimumab at Week 12p-value: <0.001Method proposed by [Liu 2014]
Comparison: Filgotinib 100 mg vs Adalimumab at Week 12p-value: 0.054Method proposed by [Liu 2014]
Comparison: Filgotinib 200 mg vs Adalimumab at Week 12p-value: 0.06995% CI: [-1, 13.6]Regression, Logistic
Comparison: Filgotinib 100 mg vs Adalimumab at Week 12p-value: 0.1895% CI: [-11.8, 2.6]Regression, Logistic
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Weeks 2, 4, and 24
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 2 | 13.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 24 | 60.6 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 4 | 25.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 2 | 8.1 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 24 | 53.1 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 4 | 20.4 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 4 | 20.9 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 2 | 9.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 24 | 50.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 2 | 3.6 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 24 | 33.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 | Week 4 | 9.3 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 2p-value: <0.00195% CI: [5.8, 13.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 2p-value: 0.00495% CI: [1.4, 7.7]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 4p-value: <0.00195% CI: [11.3, 21.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 4p-value: <0.00195% CI: [6.5, 15.8]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24p-value: <0.00195% CI: [20.6, 33.3]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24p-value: <0.00195% CI: [13.1, 25.8]Regression, Logistic
Secondary
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), 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 36, and 52
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 36 | 67.4 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 52 | 68.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 36 | 60.2 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 52 | 62.1 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 36 | 58.2 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 52 | 61.8 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 52 | 69.5 percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 36 | 74.7 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 36 | 66.5 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 | Week 52 | 67.5 percentage of participants |
Secondary
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time frame: Week 12
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filgotinib 200 mg | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | 34.1 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | 23.8 percentage of participants |
| Adalimumab | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | 23.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | 9.3 percentage of participants |
Comparison: Filgotinib 200 mg vs Adalimumab at Week 12.p-value: 0.00195% CI: [3.9, 17]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 12.p-value: <0.00195% CI: [19.6, 30]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 12.p-value: <0.00195% CI: [9.7, 19.3]Regression, Logistic
Comparison: Filgotinib 200 mg vs Adalimumab at Week 12.p-value: <0.001Method proposed by [Liu 2014]
Comparison: Filgotinib 100 mg vs Adalimumab at Week 12.p-value: 0.002Method proposed by [Liu 2014]
Comparison: Filgotinib 100 mg vs Adalimumab at Week 12.p-value: 0.9995% CI: [-6.2, 6.3]Regression, Logistic
Secondary
Percentage of Participants With no Radiographic Progression From Baseline at Week 24
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC).
Time frame: Baseline; Weeks 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0.5 | 93.8 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ SDC (1.36) | 95.8 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0 | 87.9 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0.5 | 91.1 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ SDC (1.36) | 95.0 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0 | 85.9 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0 | 86.3 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0.5 | 91.9 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ SDC (1.36) | 94.5 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0.5 | 87.2 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ SDC (1.36) | 90.3 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 24 | Change in mTSS ≤ 0 | 80.9 percentage of participants |
Comparison: Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.p-value: 0.00295% CI: [2.2, 11.1]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.p-value: 0.07395% CI: [-0.8, 8.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.p-value: 0.00995% CI: [1.5, 12.5]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.p-value: 0.06195% CI: [-0.6, 10.6]Regression, Logistic
Comparison: Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).p-value: 0.00495% CI: [1.6, 9.4]Regression, Logistic
Comparison: Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).p-value: 0.01295% CI: [0.7, 8.8]Regression, Logistic
Secondary
Percentage of Participants With no Radiographic Progression From Baseline at Week 52
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC).
Time frame: Baseline; Week 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0.5 | 92.1 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ SDC (1.83) | 95.0 percentage of participants |
| Filgotinib 200 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0 | 87.5 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0 | 81.3 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0.5 | 87.1 percentage of participants |
| Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ SDC (1.83) | 91.5 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0 | 82.4 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0.5 | 88.6 percentage of participants |
| Adalimumab | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ SDC (1.83) | 94.1 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0.5 | 83.9 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ SDC (1.83) | 90.0 percentage of participants |
| Placebo | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0 | 73.3 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0 | 77.0 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ 0.5 | 83.7 percentage of participants |
| Placebo to Filgotinib 100 mg | Percentage of Participants With no Radiographic Progression From Baseline at Week 52 | Change in mTSS ≤ SDC (1.83) | 87.6 percentage of participants |
Secondary
SF-36 MCS Score at Weeks 36, and 52
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 52 | 50.6 score on a scale | Standard Deviation 9.3 |
| Filgotinib 200 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 36 | 50.1 score on a scale | Standard Deviation 8.96 |
| Filgotinib 100 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 36 | 51.3 score on a scale | Standard Deviation 8.88 |
| Filgotinib 100 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 52 | 51.5 score on a scale | Standard Deviation 8.99 |
| Adalimumab | SF-36 MCS Score at Weeks 36, and 52 | Week 36 | 50.7 score on a scale | Standard Deviation 9.67 |
| Adalimumab | SF-36 MCS Score at Weeks 36, and 52 | Week 52 | 50.8 score on a scale | Standard Deviation 9.51 |
| Placebo | SF-36 MCS Score at Weeks 36, and 52 | Week 36 | 50.7 score on a scale | Standard Deviation 9.04 |
| Placebo | SF-36 MCS Score at Weeks 36, and 52 | Week 52 | 50.8 score on a scale | Standard Deviation 8.55 |
| Placebo to Filgotinib 100 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 52 | 50.1 score on a scale | Standard Deviation 9.21 |
| Placebo to Filgotinib 100 mg | SF-36 MCS Score at Weeks 36, and 52 | Week 36 | 50.3 score on a scale | Standard Deviation 9.47 |
Secondary
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 47.8 score on a scale | Standard Deviation 9.9 |
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 50.0 score on a scale | Standard Deviation 8.82 |
| Filgotinib 200 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 49.3 score on a scale | Standard Deviation 9.14 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 47.9 score on a scale | Standard Deviation 9.63 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 50.2 score on a scale | Standard Deviation 8.93 |
| Filgotinib 100 mg | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 49.9 score on a scale | Standard Deviation 8.9 |
| Adalimumab | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 48.9 score on a scale | Standard Deviation 10.28 |
| Adalimumab | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 47.9 score on a scale | Standard Deviation 10.04 |
| Adalimumab | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 49.3 score on a scale | Standard Deviation 10.26 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 4 | 45.8 score on a scale | Standard Deviation 10.35 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 24 | 49.2 score on a scale | Standard Deviation 9.9 |
| Placebo | SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 | Week 12 | 47.7 score on a scale | Standard Deviation 10.16 |
Secondary
SF-36 PCS Score at Weeks 36, and 52
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Time frame: Weeks 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 36 | 45.2 score on a scale | Standard Deviation 8.28 |
| Filgotinib 200 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 52 | 45.6 score on a scale | Standard Deviation 8.35 |
| Filgotinib 100 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 36 | 44.4 score on a scale | Standard Deviation 8.54 |
| Filgotinib 100 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 52 | 45.1 score on a scale | Standard Deviation 8.57 |
| Adalimumab | SF-36 PCS Score at Weeks 36, and 52 | Week 36 | 43.8 score on a scale | Standard Deviation 8.84 |
| Adalimumab | SF-36 PCS Score at Weeks 36, and 52 | Week 52 | 45.2 score on a scale | Standard Deviation 8.55 |
| Placebo | SF-36 PCS Score at Weeks 36, and 52 | Week 52 | 45.1 score on a scale | Standard Deviation 8.26 |
| Placebo | SF-36 PCS Score at Weeks 36, and 52 | Week 36 | 45.2 score on a scale | Standard Deviation 7.99 |
| Placebo to Filgotinib 100 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 36 | 43.2 score on a scale | Standard Deviation 8.82 |
| Placebo to Filgotinib 100 mg | SF-36 PCS Score at Weeks 36, and 52 | Week 52 | 44.1 score on a scale | Standard Deviation 8.88 |
Secondary
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 8.5 percentage of work time missed | Standard Deviation 21.27 |
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 4.4 percentage of work time missed | Standard Deviation 13.54 |
| Filgotinib 200 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 6.6 percentage of work time missed | Standard Deviation 17.06 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 6.6 percentage of work time missed | Standard Deviation 16.47 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 3.6 percentage of work time missed | Standard Deviation 10.24 |
| Filgotinib 100 mg | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 5.4 percentage of work time missed | Standard Deviation 14.56 |
| Adalimumab | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 7.1 percentage of work time missed | Standard Deviation 18.46 |
| Adalimumab | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 9.2 percentage of work time missed | Standard Deviation 21.99 |
| Adalimumab | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 7.2 percentage of work time missed | Standard Deviation 17.72 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 4 | 9.4 percentage of work time missed | Standard Deviation 21.41 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 24 | 10.5 percentage of work time missed | Standard Deviation 21.86 |
| Placebo | Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 | Week 12 | 9.5 percentage of work time missed | Standard Deviation 22.66 |
Secondary
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 28.3 percentage of activity impairment | Standard Deviation 23.3 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 26.0 percentage of activity impairment | Standard Deviation 22.44 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 28.7 percentage of activity impairment | Standard Deviation 23.47 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 26.3 percentage of activity impairment | Standard Deviation 22.71 |
| Adalimumab | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 31.3 percentage of activity impairment | Standard Deviation 25.44 |
| Adalimumab | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 28.1 percentage of activity impairment | Standard Deviation 24.38 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 28.6 percentage of activity impairment | Standard Deviation 23.57 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 28.3 percentage of activity impairment | Standard Deviation 22.47 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 32.3 percentage of activity impairment | Standard Deviation 23.62 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 28.9 percentage of activity impairment | Standard Deviation 23.07 |
Secondary
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 44.6 percentage of activity impairment | Standard Deviation 24.18 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 30.2 percentage of activity impairment | Standard Deviation 24.69 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 35.1 percentage of activity impairment | Standard Deviation 23.86 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 46.2 percentage of activity impairment | Standard Deviation 24.05 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 30.4 percentage of activity impairment | Standard Deviation 23.07 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 36.6 percentage of activity impairment | Standard Deviation 24.51 |
| Adalimumab | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 38.3 percentage of activity impairment | Standard Deviation 25.57 |
| Adalimumab | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 46.4 percentage of activity impairment | Standard Deviation 23.84 |
| Adalimumab | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 32.5 percentage of activity impairment | Standard Deviation 24.4 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 52.1 percentage of activity impairment | Standard Deviation 23.41 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 39.3 percentage of activity impairment | Standard Deviation 23.69 |
| Placebo | WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 44.3 percentage of activity impairment | Standard Deviation 23.73 |
Secondary
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 36 | 20.2 percentage of impairment while working | Standard Deviation 19.54 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 52 | 18.2 percentage of impairment while working | Standard Deviation 18.83 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 36 | 19.6 percentage of impairment while working | Standard Deviation 20.27 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 52 | 17.3 percentage of impairment while working | Standard Deviation 19.25 |
| Adalimumab | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 36 | 21.2 percentage of impairment while working | Standard Deviation 20.74 |
| Adalimumab | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 52 | 20.8 percentage of impairment while working | Standard Deviation 21.78 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 52 | 22.3 percentage of impairment while working | Standard Deviation 21.82 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 36 | 21.5 percentage of impairment while working | Standard Deviation 18.72 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 36 | 25.8 percentage of impairment while working | Standard Deviation 23.51 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 | Week 52 | 19.5 percentage of impairment while working | Standard Deviation 20.04 |
Secondary
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 34.3 percentage of impairment while working | Standard Deviation 22.69 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 22.0 percentage of impairment while working | Standard Deviation 21.28 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 26.3 percentage of impairment while working | Standard Deviation 21.07 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 36.9 percentage of impairment while working | Standard Deviation 24.01 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 21.0 percentage of impairment while working | Standard Deviation 20.74 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 26.9 percentage of impairment while working | Standard Deviation 22.57 |
| Adalimumab | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 27.6 percentage of impairment while working | Standard Deviation 21.51 |
| Adalimumab | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 35.6 percentage of impairment while working | Standard Deviation 22.39 |
| Adalimumab | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 25.7 percentage of impairment while working | Standard Deviation 21.99 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 4 | 42.5 percentage of impairment while working | Standard Deviation 23.54 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 24 | 30.9 percentage of impairment while working | Standard Deviation 23.11 |
| Placebo | WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 | Week 12 | 34.0 percentage of impairment while working | Standard Deviation 21.98 |
Secondary
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 23.3 percentage of work productivity loss | Standard Deviation 22.02 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 20.6 percentage of work productivity loss | Standard Deviation 21.74 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 23.9 percentage of work productivity loss | Standard Deviation 23.98 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 20.5 percentage of work productivity loss | Standard Deviation 22.15 |
| Adalimumab | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 23.8 percentage of work productivity loss | Standard Deviation 22.95 |
| Adalimumab | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 24.3 percentage of work productivity loss | Standard Deviation 24.77 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 25.7 percentage of work productivity loss | Standard Deviation 24.32 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 24.0 percentage of work productivity loss | Standard Deviation 21.33 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 36 | 29.1 percentage of work productivity loss | Standard Deviation 26.79 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 | Week 52 | 22.3 percentage of work productivity loss | Standard Deviation 24.1 |
Secondary
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity.
Time frame: Weeks 4, 12, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 37.0 percentage of work productivity loss | Standard Deviation 24.64 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 24.4 percentage of work productivity loss | Standard Deviation 23.06 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 29.5 percentage of work productivity loss | Standard Deviation 24.25 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 39.5 percentage of work productivity loss | Standard Deviation 25.17 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 23.2 percentage of work productivity loss | Standard Deviation 22.64 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 29.3 percentage of work productivity loss | Standard Deviation 24.73 |
| Adalimumab | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 30.7 percentage of work productivity loss | Standard Deviation 24.34 |
| Adalimumab | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 38.4 percentage of work productivity loss | Standard Deviation 24.59 |
| Adalimumab | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 29.1 percentage of work productivity loss | Standard Deviation 23.88 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 4 | 45.1 percentage of work productivity loss | Standard Deviation 25.18 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 24 | 34.9 percentage of work productivity loss | Standard Deviation 26.04 |
| Placebo | WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 | Week 12 | 36.7 percentage of work productivity loss | Standard Deviation 24.27 |
Secondary
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
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 36, and 52
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 36 | 5.5 percentage of work time missed | Standard Deviation 16.17 |
| Filgotinib 200 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 52 | 4.8 percentage of work time missed | Standard Deviation 14.39 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 36 | 7.7 percentage of work time missed | Standard Deviation 19.46 |
| Filgotinib 100 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 52 | 5.4 percentage of work time missed | Standard Deviation 15.1 |
| Adalimumab | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 36 | 7.0 percentage of work time missed | Standard Deviation 19.65 |
| Adalimumab | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 52 | 7.4 percentage of work time missed | Standard Deviation 20.12 |
| Placebo | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 52 | 5.5 percentage of work time missed | Standard Deviation 13.24 |
| Placebo | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 36 | 6.8 percentage of work time missed | Standard Deviation 19.79 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 36 | 8.4 percentage of work time missed | Standard Deviation 19.97 |
| Placebo to Filgotinib 100 mg | WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 | Week 52 | 5.8 percentage of work time missed | Standard Deviation 14.29 |