Trial Outcomes & Findings for Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment (NCT NCT02873936)
NCT ID: NCT02873936
Last Updated: 2021-05-13
Results Overview
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
Week 12
Results posted on
2021-05-13
Participant Flow
Participants were enrolled at study sites in Australia, Asia, Europe, North America, and South America. The first participant was screened on 27 July 2016. The last study visit occurred on 26 June 2018.
688 participants were screened. The enrolled participants continued to receive ongoing therapy with permitted protocol specified Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) (ie, methotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide). MTX was not permitted to be used in combination with leflunomide.
Participant milestones
| Measure |
Filgotinib 200 mg
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
148
|
153
|
148
|
|
Overall Study
COMPLETED
|
135
|
130
|
116
|
|
Overall Study
NOT COMPLETED
|
13
|
23
|
32
|
Reasons for withdrawal
| Measure |
Filgotinib 200 mg
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrew Consent
|
4
|
11
|
20
|
|
Overall Study
Investigator's Discretion
|
3
|
5
|
4
|
|
Overall Study
Adverse Event
|
3
|
5
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Non-compliance With Study Drug
|
1
|
0
|
1
|
|
Overall Study
Randomized but not Dosed
|
1
|
0
|
0
|
Baseline Characteristics
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Baseline characteristics by cohort
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Total
n=448 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
55.0 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
56.0 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
56.0 years
STANDARD_DEVIATION 12.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
360 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
88 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian: Japanese
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian: Chinese/Taiwanese/Hong Kong Chinese
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian: Vietnamese
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian: Korean
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Asian: Other
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
110 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
316 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
26 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
107 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
120 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
339 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
87 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
255 Participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
South Korea
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
Poland
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
Mexico
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Region of Enrollment
Argentina
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Full Analysis Set included all randomized participants who received at least 1 dose of study drug.
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
|
66.0 percentage of participants
Interval 58.0 to 74.0
|
57.5 percentage of participants
Interval 49.4 to 65.7
|
31.1 percentage of participants
Interval 23.3 to 38.9
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 \[0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices\]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled)\] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Baseline
|
1.70 score on a scale
Standard Deviation 0.656
|
1.64 score on a scale
Standard Deviation 0.683
|
1.65 score on a scale
Standard Deviation 0.633
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Change from Baseline at Week 12
|
-0.55 score on a scale
Standard Deviation 0.590
|
-0.48 score on a scale
Standard Deviation 0.602
|
-0.23 score on a scale
Standard Deviation 0.547
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set were analyzed.
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP=hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12
|
40.8 percentage of participants
Interval 32.5 to 49.1
|
37.3 percentage of participants
Interval 29.3 to 45.2
|
15.5 percentage of participants
Interval 9.4 to 21.7
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Baseline
|
30.4 score on a scale
Standard Deviation 7.75
|
31.7 score on a scale
Standard Deviation 7.76
|
31.1 score on a scale
Standard Deviation 8.17
|
|
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Change from Baseline at Week 12
|
7.6 score on a scale
Standard Deviation 7.68
|
6.8 score on a scale
Standard Deviation 8.22
|
3.6 score on a scale
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set were analyzed.
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24
|
30.6 percentage of participants
Interval 22.8 to 38.4
|
26.1 percentage of participants
Interval 18.9 to 33.4
|
12.2 percentage of participants
Interval 6.6 to 17.8
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
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).
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=152 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=147 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Baseline
|
24.2 score on a scale
Standard Deviation 11.47
|
23.7 score on a scale
Standard Deviation 12.30
|
25.4 score on a scale
Standard Deviation 10.89
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Change from Baseline at Week 12
|
9.6 score on a scale
Standard Deviation 11.24
|
8.3 score on a scale
Standard Deviation 10.80
|
4.5 score on a scale
Standard Deviation 10.37
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
Week 4
|
22.4 percentage of participants
Interval 15.4 to 29.5
|
21.6 percentage of participants
Interval 14.7 to 28.4
|
7.4 percentage of participants
Interval 2.9 to 12.0
|
|
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
Week 12
|
42.9 percentage of participants
Interval 34.5 to 51.2
|
32.0 percentage of participants
Interval 24.3 to 39.7
|
14.9 percentage of participants
Interval 8.8 to 20.9
|
|
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
Week 24
|
45.6 percentage of participants
Interval 37.2 to 54.0
|
35.3 percentage of participants
Interval 27.4 to 43.2
|
18.9 percentage of participants
Interval 12.3 to 25.6
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
Week 4
|
6.1 percentage of participants
Interval 1.9 to 10.3
|
8.5 percentage of participants
Interval 3.8 to 13.2
|
2.7 percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
Week 12
|
21.8 percentage of participants
Interval 14.8 to 28.8
|
14.4 percentage of participants
Interval 8.5 to 20.3
|
6.8 percentage of participants
Interval 2.4 to 11.1
|
|
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
Week 24
|
32.0 percentage of participants
Interval 24.1 to 39.9
|
20.3 percentage of participants
Interval 13.6 to 27.0
|
8.1 percentage of participants
Interval 3.4 to 12.8
|
SECONDARY outcome
Timeframe: Weeks 4, and 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
Week 4
|
51.7 percentage of participants
Interval 43.3 to 60.1
|
44.4 percentage of participants
Interval 36.2 to 52.6
|
25.7 percentage of participants
Interval 18.3 to 33.1
|
|
Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
Week 24
|
69.4 percentage of participants
Interval 61.6 to 77.2
|
54.9 percentage of participants
Interval 46.7 to 63.1
|
34.5 percentage of participants
Interval 26.5 to 42.5
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
Baseline
|
28.0 tender joint count
Standard Deviation 16.1
|
26.0 tender joint count
Standard Deviation 15.4
|
27.0 tender joint count
Standard Deviation 15.5
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-13.0 tender joint count
Standard Deviation 13.5
|
-11.0 tender joint count
Standard Deviation 11.0
|
-8.0 tender joint count
Standard Deviation 13.8
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-18.0 tender joint count
Standard Deviation 14.1
|
-16.0 tender joint count
Standard Deviation 11.8
|
-12.0 tender joint count
Standard Deviation 13.4
|
|
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-22.0 tender joint count
Standard Deviation 14.2
|
-19.0 tender joint count
Standard Deviation 13.0
|
-17.0 tender joint count
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
Baseline
|
18.0 swollen joint count
Standard Deviation 12.5
|
17.0 swollen joint count
Standard Deviation 12.4
|
17.0 swollen joint count
Standard Deviation 9.7
|
|
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-10.0 swollen joint count
Standard Deviation 10.6
|
-7.0 swollen joint count
Standard Deviation 9.2
|
-7.0 swollen joint count
Standard Deviation 8.8
|
|
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-12.0 swollen joint count
Standard Deviation 10.5
|
-10.0 swollen joint count
Standard Deviation 8.6
|
-8.0 swollen joint count
Standard Deviation 8.9
|
|
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-14.0 swollen joint count
Standard Deviation 10.3
|
-13.0 swollen joint count
Standard Deviation 10.0
|
-12.0 swollen joint count
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
Baseline
|
68.0 score on a scale
Standard Deviation 20.6
|
69.0 score on a scale
Standard Deviation 20.2
|
70.0 score on a scale
Standard Deviation 18.0
|
|
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-21.0 score on a scale
Standard Deviation 23.2
|
-20.0 score on a scale
Standard Deviation 26.1
|
-10.0 score on a scale
Standard Deviation 22.6
|
|
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-31.0 score on a scale
Standard Deviation 25.9
|
-27.0 score on a scale
Standard Deviation 28.4
|
-14.0 score on a scale
Standard Deviation 26.3
|
|
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-38.0 score on a scale
Standard Deviation 26.8
|
-34.0 score on a scale
Standard Deviation 28.1
|
-24.0 score on a scale
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 3 (maximum disease activity). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
Baseline
|
69.0 score on a scale
Standard Deviation 17.6
|
68.0 score on a scale
Standard Deviation 18.7
|
66.0 score on a scale
Standard Deviation 16.7
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-32.0 score on a scale
Standard Deviation 25.2
|
-30.0 score on a scale
Standard Deviation 24.3
|
-19.0 score on a scale
Standard Deviation 22.2
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-45.0 score on a scale
Standard Deviation 25.2
|
-41.0 score on a scale
Standard Deviation 26.7
|
-28.0 score on a scale
Standard Deviation 26.9
|
|
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-53.0 score on a scale
Standard Deviation 22.7
|
-45.0 score on a scale
Standard Deviation 23.8
|
-41.0 score on a scale
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-22.0 score on a scale
Standard Deviation 24.2
|
-20.0 score on a scale
Standard Deviation 26.3
|
-8.0 score on a scale
Standard Deviation 22.6
|
|
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
Baseline
|
66.0 score on a scale
Standard Deviation 21.6
|
67.0 score on a scale
Standard Deviation 21.7
|
68.0 score on a scale
Standard Deviation 19.9
|
|
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-30.0 score on a scale
Standard Deviation 27.9
|
-27.0 score on a scale
Standard Deviation 30.9
|
-14.0 score on a scale
Standard Deviation 27.0
|
|
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-37.0 score on a scale
Standard Deviation 28.1
|
-35.0 score on a scale
Standard Deviation 29.1
|
-24.0 score on a scale
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
Baseline
|
1.70 score on a scale
Standard Deviation 0.656
|
1.64 score on a scale
Standard Deviation 0.683
|
1.65 score on a scale
Standard Deviation 0.633
|
|
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
Change from Baseline at Week 4
|
-0.39 score on a scale
Standard Deviation 0.493
|
-0.32 score on a scale
Standard Deviation 0.539
|
-0.18 score on a scale
Standard Deviation 0.444
|
|
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
Change from Baseline at Week 24
|
-0.75 score on a scale
Standard Deviation 0.620
|
-0.60 score on a scale
Standard Deviation 0.660
|
-0.42 score on a scale
Standard Deviation 0.600
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Baseline
|
17.21 mg/L
Standard Deviation 18.275
|
21.49 mg/L
Standard Deviation 28.206
|
16.42 mg/L
Standard Deviation 18.321
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-9.55 mg/L
Standard Deviation 18.421
|
-12.15 mg/L
Standard Deviation 25.502
|
1.04 mg/L
Standard Deviation 13.942
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-11.86 mg/L
Standard Deviation 19.760
|
-12.02 mg/L
Standard Deviation 26.226
|
0.57 mg/L
Standard Deviation 15.178
|
|
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-10.87 mg/L
Standard Deviation 19.083
|
-11.12 mg/L
Standard Deviation 27.766
|
-1.50 mg/L
Standard Deviation 15.889
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24
Week 4
|
60.4 percentage of participants
Interval 52.1 to 68.8
|
54.7 percentage of participants
Interval 46.4 to 63.1
|
40.3 percentage of participants
Interval 31.9 to 48.6
|
|
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24
Week 12
|
66.7 percentage of participants
Interval 58.6 to 74.7
|
66.2 percentage of participants
Interval 58.3 to 74.2
|
44.4 percentage of participants
Interval 36.0 to 52.9
|
|
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24
Week 24
|
68.8 percentage of participants
Interval 60.8 to 76.7
|
54.1 percentage of participants
Interval 45.7 to 62.4
|
35.4 percentage of participants
Interval 27.3 to 43.6
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
Baseline
|
5.9 score on a scale
Standard Deviation 1.03
|
5.9 score on a scale
Standard Deviation 0.98
|
5.9 score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-1.7 score on a scale
Standard Deviation 1.16
|
-1.5 score on a scale
Standard Deviation 1.14
|
-0.9 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-2.4 score on a scale
Standard Deviation 1.32
|
-2.3 score on a scale
Standard Deviation 1.38
|
-1.3 score on a scale
Standard Deviation 1.33
|
|
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-2.9 score on a scale
Standard Deviation 1.29
|
-2.6 score on a scale
Standard Deviation 1.32
|
-2.1 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Weeks 4, and 24Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24
Week 4
|
21.8 percentage of participants
Interval 14.8 to 28.8
|
22.2 percentage of participants
Interval 15.3 to 29.1
|
9.5 percentage of participants
Interval 4.4 to 14.5
|
|
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24
Week 24
|
48.3 percentage of participants
Interval 39.9 to 56.7
|
37.9 percentage of participants
Interval 29.9 to 45.9
|
20.9 percentage of participants
Interval 14.1 to 27.8
|
SECONDARY outcome
Timeframe: Weeks 4, and 12Population: Participants in the Full Analysis Set were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
Week 12
|
22.4 percentage of participants
Interval 15.4 to 29.5
|
25.5 percentage of participants
Interval 18.3 to 32.7
|
8.1 percentage of participants
Interval 3.4 to 12.8
|
|
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
Week 4
|
10.2 percentage of participants
Interval 5.0 to 15.4
|
11.8 percentage of participants
Interval 6.3 to 17.2
|
2.7 percentage of participants
Interval 0.0 to 5.7
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
Week 4
|
26.9 percent improvement
Standard Deviation 24.58
|
25.8 percent improvement
Standard Deviation 27.09
|
13.7 percent improvement
Standard Deviation 19.42
|
|
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
Week 12
|
43.4 percent improvement
Standard Deviation 29.26
|
37.1 percent improvement
Standard Deviation 30.29
|
19.7 percent improvement
Standard Deviation 25.44
|
|
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
Week 24
|
53.5 percent improvement
Standard Deviation 27.52
|
45.5 percent improvement
Standard Deviation 32.16
|
31.9 percent improvement
Standard Deviation 29.52
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 4 · Good Response
|
32 Participants
|
34 Participants
|
13 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 4 · Moderate Response
|
74 Participants
|
65 Participants
|
53 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 4 · No Response
|
38 Participants
|
46 Participants
|
63 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 12 · Good Response
|
58 Participants
|
56 Participants
|
23 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 12 · Moderate Response
|
65 Participants
|
58 Participants
|
51 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 12 · No Response
|
13 Participants
|
23 Participants
|
54 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 24 · Good Response
|
70 Participants
|
58 Participants
|
31 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 24 · Moderate Response
|
43 Participants
|
47 Participants
|
45 Participants
|
|
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Week 24 · No Response
|
8 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
Baseline
|
41.7 score on a scale
Standard Deviation 14.23
|
40.4 score on a scale
Standard Deviation 13.23
|
41.4 score on a scale
Standard Deviation 12.00
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-19.1 score on a scale
Standard Deviation 13.06
|
-16.8 score on a scale
Standard Deviation 12.95
|
-12.8 score on a scale
Standard Deviation 13.71
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-26.2 score on a scale
Standard Deviation 15.04
|
-23.8 score on a scale
Standard Deviation 14.33
|
-17.3 score on a scale
Standard Deviation 15.22
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-30.9 score on a scale
Standard Deviation 13.77
|
-27.8 score on a scale
Standard Deviation 13.54
|
-25.4 score on a scale
Standard Deviation 14.40
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-27.6 score on a scale
Standard Deviation 15.54
|
-24.9 score on a scale
Standard Deviation 15.01
|
-17.2 score on a scale
Standard Deviation 15.52
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
Baseline
|
43.4 score on a scale
Standard Deviation 14.64
|
42.6 score on a scale
Standard Deviation 14.16
|
43.0 score on a scale
Standard Deviation 12.33
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-20.1 score on a scale
Standard Deviation 13.73
|
-18.1 score on a scale
Standard Deviation 13.19
|
-12.9 score on a scale
Standard Deviation 14.01
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-32.1 score on a scale
Standard Deviation 14.41
|
-28.8 score on a scale
Standard Deviation 14.19
|
-24.9 score on a scale
Standard Deviation 14.84
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
SF-36 PCS Score at Weeks 4, 12, and 24
Week 4
|
35.4 score on a scale
Standard Deviation 8.72
|
36.4 score on a scale
Standard Deviation 9.29
|
33.7 score on a scale
Standard Deviation 8.67
|
|
SF-36 PCS Score at Weeks 4, 12, and 24
Week 12
|
38.3 score on a scale
Standard Deviation 10.14
|
38.6 score on a scale
Standard Deviation 9.39
|
35.1 score on a scale
Standard Deviation 9.90
|
|
SF-36 PCS Score at Weeks 4, 12, and 24
Week 24
|
40.4 score on a scale
Standard Deviation 9.64
|
40.3 score on a scale
Standard Deviation 10.31
|
37.7 score on a scale
Standard Deviation 9.09
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Baseline
|
30.4 score on a scale
Standard Deviation 7.75
|
31.7 score on a scale
Standard Deviation 7.76
|
31.1 score on a scale
Standard Deviation 8.17
|
|
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Change from Baseline at Week 4
|
5.1 score on a scale
Standard Deviation 6.34
|
4.5 score on a scale
Standard Deviation 6.53
|
2.5 score on a scale
Standard Deviation 5.91
|
|
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Change from Baseline at Week 24
|
9.4 score on a scale
Standard Deviation 8.23
|
9.0 score on a scale
Standard Deviation 8.44
|
6.6 score on a scale
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Week 4
|
48.0 score on a scale
Standard Deviation 11.48
|
47.3 score on a scale
Standard Deviation 11.51
|
45.5 score on a scale
Standard Deviation 11.11
|
|
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Week 12
|
50.2 score on a scale
Standard Deviation 10.58
|
48.8 score on a scale
Standard Deviation 11.02
|
47.9 score on a scale
Standard Deviation 11.01
|
|
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Week 24
|
50.6 score on a scale
Standard Deviation 10.35
|
49.5 score on a scale
Standard Deviation 10.72
|
49.1 score on a scale
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Baseline
|
44.5 score on a scale
Standard Deviation 11.97
|
44.2 score on a scale
Standard Deviation 11.59
|
44.3 score on a scale
Standard Deviation 11.32
|
|
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
3.5 score on a scale
Standard Deviation 9.17
|
3.0 score on a scale
Standard Deviation 9.03
|
1.2 score on a scale
Standard Deviation 9.34
|
|
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
5.3 score on a scale
Standard Deviation 10.60
|
4.6 score on a scale
Standard Deviation 9.76
|
3.7 score on a scale
Standard Deviation 9.17
|
|
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
6.5 score on a scale
Standard Deviation 12.50
|
4.6 score on a scale
Standard Deviation 9.22
|
4.3 score on a scale
Standard Deviation 9.44
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
FACIT-Fatigue Score at Weeks 4, 12, and 24
Week 4
|
30.4 score on a scale
Standard Deviation 12.48
|
30.3 score on a scale
Standard Deviation 12.30
|
27.9 score on a scale
Standard Deviation 11.29
|
|
FACIT-Fatigue Score at Weeks 4, 12, and 24
Week 12
|
34.0 score on a scale
Standard Deviation 12.08
|
32.1 score on a scale
Standard Deviation 13.66
|
30.4 score on a scale
Standard Deviation 11.79
|
|
FACIT-Fatigue Score at Weeks 4, 12, and 24
Week 24
|
36.3 score on a scale
Standard Deviation 11.58
|
34.4 score on a scale
Standard Deviation 12.51
|
33.3 score on a scale
Standard Deviation 11.26
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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).
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=152 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=147 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Baseline
|
24.2 score on a scale
Standard Deviation 11.47
|
23.7 score on a scale
Standard Deviation 12.30
|
25.4 score on a scale
Standard Deviation 10.89
|
|
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Change from Baseline at Week 4
|
6.2 score on a scale
Standard Deviation 10.20
|
6.4 score on a scale
Standard Deviation 9.87
|
2.2 score on a scale
Standard Deviation 8.92
|
|
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Change from Baseline at Week 24
|
11.6 score on a scale
Standard Deviation 11.67
|
9.8 score on a scale
Standard Deviation 10.39
|
7.0 score on a scale
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 24 · No Problems
|
51 Participants
|
41 Participants
|
20 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 24 · Slight Problems
|
45 Participants
|
32 Participants
|
41 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 24 · Moderate Problems
|
18 Participants
|
28 Participants
|
24 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 24 · Severe Problems
|
8 Participants
|
7 Participants
|
4 Participants
|
|
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
|
2 Participants
|
1 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 4 · No Problems
|
8 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 4 · Slight Problems
|
69 Participants
|
57 Participants
|
37 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 4 · Moderate Problems
|
45 Participants
|
50 Participants
|
62 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 4 · Severe Problems
|
19 Participants
|
22 Participants
|
36 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 4 · Extreme Problems
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 12 · No Problems
|
21 Participants
|
16 Participants
|
10 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 12 · Slight Problems
|
68 Participants
|
56 Participants
|
36 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 12 · Moderate Problems
|
34 Participants
|
56 Participants
|
57 Participants
|
|
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
|
14 Participants
|
28 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 12 · Extreme Problems
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 24 · No Problems
|
18 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 24 · Slight Problems
|
61 Participants
|
42 Participants
|
32 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Pain/Discomfort: Week 24 · Moderate Problems
|
31 Participants
|
36 Participants
|
33 Participants
|
|
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
|
10 Participants
|
14 Participants
|
|
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
|
2 Participants
|
1 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 4 · No Problems
|
78 Participants
|
77 Participants
|
60 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 4 · Slight Problems
|
33 Participants
|
41 Participants
|
43 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 4 · Moderate Problems
|
25 Participants
|
21 Participants
|
34 Participants
|
|
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
|
4 Participants
|
5 Participants
|
|
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
|
1 Participants
|
2 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 12 · No Problems
|
79 Participants
|
84 Participants
|
71 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 12 · Slight Problems
|
33 Participants
|
30 Participants
|
34 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 12 · Moderate Problems
|
23 Participants
|
26 Participants
|
23 Participants
|
|
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
|
3 Participants
|
3 Participants
|
|
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
|
0 Participants
|
1 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 24 · No Problems
|
70 Participants
|
62 Participants
|
50 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 24 · Slight Problems
|
33 Participants
|
30 Participants
|
19 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 24 · Moderate Problems
|
16 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Anxiety/Depression: Week 24 · Severe Problems
|
4 Participants
|
4 Participants
|
6 Participants
|
|
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
|
1 Participants
|
0 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 4 · No Problems
|
34 Participants
|
45 Participants
|
32 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 4 · Slight Problems
|
58 Participants
|
49 Participants
|
49 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 4 · Moderate Problems
|
38 Participants
|
33 Participants
|
36 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 4 · Severe Problems
|
15 Participants
|
16 Participants
|
25 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 4 · Extreme Problems
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 12 · No Problems
|
47 Participants
|
57 Participants
|
38 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 12 · Slight Problems
|
55 Participants
|
48 Participants
|
46 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 12 · Moderate Problems
|
25 Participants
|
29 Participants
|
29 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 12 · Severe Problems
|
13 Participants
|
9 Participants
|
19 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 24 · No Problems
|
51 Participants
|
38 Participants
|
32 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 24 · Slight Problems
|
38 Participants
|
45 Participants
|
29 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 24 · Moderate Problems
|
23 Participants
|
18 Participants
|
24 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 24 · Severe Problems
|
11 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Mobility: Week 24 · Extreme Problems
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 4 · No Problems
|
67 Participants
|
67 Participants
|
49 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 4 · Slight Problems
|
45 Participants
|
43 Participants
|
52 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 4 · Moderate Problems
|
24 Participants
|
27 Participants
|
28 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 4 · Severe Problems
|
6 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 4 · Extreme Problems
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 12 · No Problems
|
79 Participants
|
78 Participants
|
56 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 12 · Slight Problems
|
38 Participants
|
46 Participants
|
44 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 12 · Moderate Problems
|
16 Participants
|
15 Participants
|
21 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 12 · Severe Problems
|
6 Participants
|
4 Participants
|
11 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 24 · No Problems
|
83 Participants
|
58 Participants
|
45 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 24 · Slight Problems
|
23 Participants
|
31 Participants
|
31 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Self-care: Week 24 · Moderate Problems
|
13 Participants
|
16 Participants
|
10 Participants
|
|
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
|
4 Participants
|
4 Participants
|
|
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
|
1 Participants
|
0 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 4 · No Problems
|
27 Participants
|
38 Participants
|
22 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 4 · Slight Problems
|
65 Participants
|
50 Participants
|
44 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 4 · Moderate Problems
|
26 Participants
|
38 Participants
|
49 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 4 · Severe Problems
|
19 Participants
|
12 Participants
|
25 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 4 · Extreme Problems
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 12 · No Problems
|
47 Participants
|
51 Participants
|
26 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 12 · Slight Problems
|
54 Participants
|
41 Participants
|
48 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 12 · Moderate Problems
|
25 Participants
|
37 Participants
|
38 Participants
|
|
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Usual Activities: Week 12 · Severe Problems
|
15 Participants
|
11 Participants
|
20 Participants
|
|
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
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Week 24
|
70.0 score on a scale
Standard Deviation 21.8
|
69.0 score on a scale
Standard Deviation 21.3
|
62.0 score on a scale
Standard Deviation 23.0
|
|
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Week 4
|
59.0 score on a scale
Standard Deviation 22.1
|
60.0 score on a scale
Standard Deviation 19.8
|
52.0 score on a scale
Standard Deviation 24.2
|
|
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Week 12
|
66.0 score on a scale
Standard Deviation 23.2
|
65.0 score on a scale
Standard Deviation 22.2
|
58.0 score on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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).
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=152 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=147 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
10.0 score on a scale
Standard Deviation 27.6
|
14.0 score on a scale
Standard Deviation 26.8
|
6.0 score on a scale
Standard Deviation 26.0
|
|
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Baseline
|
49.0 score on a scale
Standard Deviation 24.7
|
46.0 score on a scale
Standard Deviation 24.0
|
46.0 score on a scale
Standard Deviation 22.4
|
|
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
17.0 score on a scale
Standard Deviation 30.9
|
19.0 score on a scale
Standard Deviation 26.4
|
12.0 score on a scale
Standard Deviation 26.5
|
|
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
22.0 score on a scale
Standard Deviation 30.8
|
25.0 score on a scale
Standard Deviation 26.7
|
17.0 score on a scale
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Week 4
|
8.8 percentage of work time missed
Standard Deviation 21.01
|
18.2 percentage of work time missed
Standard Deviation 30.93
|
14.3 percentage of work time missed
Standard Deviation 27.52
|
|
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Week 12
|
5.6 percentage of work time missed
Standard Deviation 13.79
|
14.6 percentage of work time missed
Standard Deviation 27.13
|
12.1 percentage of work time missed
Standard Deviation 24.39
|
|
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Week 24
|
7.6 percentage of work time missed
Standard Deviation 16.37
|
13.8 percentage of work time missed
Standard Deviation 26.23
|
8.5 percentage of work time missed
Standard Deviation 18.08
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Week 4
|
27.4 percentage of impairment while working
Standard Deviation 22.50
|
37.8 percentage of impairment while working
Standard Deviation 25.43
|
48.6 percentage of impairment while working
Standard Deviation 29.81
|
|
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Week 12
|
23.9 percentage of impairment while working
Standard Deviation 20.99
|
34.8 percentage of impairment while working
Standard Deviation 27.22
|
44.2 percentage of impairment while working
Standard Deviation 29.21
|
|
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Week 24
|
28.0 percentage of impairment while working
Standard Deviation 27.57
|
25.6 percentage of impairment while working
Standard Deviation 22.10
|
36.7 percentage of impairment while working
Standard Deviation 26.95
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Week 4
|
30.8 percentage of overall work productivity
Standard Deviation 24.36
|
43.1 percentage of overall work productivity
Standard Deviation 27.82
|
51.3 percentage of overall work productivity
Standard Deviation 30.85
|
|
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Week 12
|
26.9 percentage of overall work productivity
Standard Deviation 24.20
|
39.5 percentage of overall work productivity
Standard Deviation 29.37
|
46.9 percentage of overall work productivity
Standard Deviation 30.63
|
|
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Week 24
|
31.7 percentage of overall work productivity
Standard Deviation 29.94
|
31.4 percentage of overall work productivity
Standard Deviation 25.65
|
39.8 percentage of overall work productivity
Standard Deviation 29.49
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=147 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Week 4
|
49.6 percentage of activity impairment
Standard Deviation 26.56
|
49.9 percentage of activity impairment
Standard Deviation 27.43
|
60.3 percentage of activity impairment
Standard Deviation 25.49
|
|
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Week 12
|
40.3 percentage of activity impairment
Standard Deviation 26.75
|
45.5 percentage of activity impairment
Standard Deviation 28.23
|
53.0 percentage of activity impairment
Standard Deviation 27.26
|
|
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Week 24
|
33.3 percentage of activity impairment
Standard Deviation 24.61
|
37.5 percentage of activity impairment
Standard Deviation 27.00
|
45.7 percentage of activity impairment
Standard Deviation 25.57
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=35 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=54 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=48 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Baseline
|
11.3 percentage of work time missed
Standard Deviation 16.31
|
19.2 percentage of work time missed
Standard Deviation 28.57
|
10.8 percentage of work time missed
Standard Deviation 25.65
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-4.3 percentage of work time missed
Standard Deviation 20.98
|
-3.4 percentage of work time missed
Standard Deviation 24.57
|
4.0 percentage of work time missed
Standard Deviation 20.75
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-3.6 percentage of work time missed
Standard Deviation 17.60
|
-7.0 percentage of work time missed
Standard Deviation 30.93
|
3.8 percentage of work time missed
Standard Deviation 18.40
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-4.6 percentage of work time missed
Standard Deviation 22.50
|
-3.1 percentage of work time missed
Standard Deviation 34.28
|
3.7 percentage of work time missed
Standard Deviation 25.13
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=35 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=51 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=46 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Baseline
|
46.9 percentage of impairment while working
Standard Deviation 24.71
|
51.0 percentage of impairment while working
Standard Deviation 27.95
|
55.7 percentage of impairment while working
Standard Deviation 26.64
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-19.1 percentage of impairment while working
Standard Deviation 25.63
|
-13.1 percentage of impairment while working
Standard Deviation 25.75
|
-5.3 percentage of impairment while working
Standard Deviation 25.52
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-20.0 percentage of impairment while working
Standard Deviation 25.56
|
-18.8 percentage of impairment while working
Standard Deviation 28.64
|
-10.8 percentage of impairment while working
Standard Deviation 20.32
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-18.6 percentage of impairment while working
Standard Deviation 22.48
|
-28.7 percentage of impairment while working
Standard Deviation 25.26
|
-20.0 percentage of impairment while working
Standard Deviation 31.36
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=35 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=51 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=46 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Baseline
|
52.0 percentage of overall work productivity
Standard Deviation 24.02
|
55.8 percentage of overall work productivity
Standard Deviation 30.53
|
56.7 percentage of overall work productivity
Standard Deviation 27.60
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-20.9 percentage of overall work productivity
Standard Deviation 28.94
|
-12.3 percentage of overall work productivity
Standard Deviation 28.05
|
-3.4 percentage of overall work productivity
Standard Deviation 25.48
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-22.8 percentage of overall work productivity
Standard Deviation 29.20
|
-19.5 percentage of overall work productivity
Standard Deviation 31.49
|
-8.3 percentage of overall work productivity
Standard Deviation 20.16
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-20.5 percentage of overall work productivity
Standard Deviation 26.20
|
-26.4 percentage of overall work productivity
Standard Deviation 29.87
|
-16.7 percentage of overall work productivity
Standard Deviation 33.28
|
SECONDARY outcome
Timeframe: Baseline; Weeks 4, 12, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
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.
Outcome measures
| Measure |
Filgotinib 200 mg
n=146 Participants
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=152 Participants
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=147 Participants
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Baseline
|
65.6 percentage of activity impairment
Standard Deviation 22.16
|
64.6 percentage of activity impairment
Standard Deviation 23.07
|
65.4 percentage of activity impairment
Standard Deviation 23.33
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 4
|
-16.0 percentage of activity impairment
Standard Deviation 24.64
|
-14.3 percentage of activity impairment
Standard Deviation 22.89
|
-4.7 percentage of activity impairment
Standard Deviation 25.06
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 12
|
-25.0 percentage of activity impairment
Standard Deviation 26.81
|
-19.2 percentage of activity impairment
Standard Deviation 28.32
|
-11.3 percentage of activity impairment
Standard Deviation 25.75
|
|
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Change from Baseline at Week 24
|
-32.5 percentage of activity impairment
Standard Deviation 27.37
|
-27.1 percentage of activity impairment
Standard Deviation 27.97
|
-18.4 percentage of activity impairment
Standard Deviation 31.23
|
Adverse Events
Filgotinib 200 mg
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Filgotinib 100 mg
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Filgotinib 200 mg
n=147 participants at risk
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 participants at risk
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 participants at risk
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
2/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.65%
1/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.68%
1/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.68%
1/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Filgotinib 200 mg
n=147 participants at risk
Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 weeks.
|
Filgotinib 100 mg
n=153 participants at risk
Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
Placebo
n=148 participants at risk
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.8%
7/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.2%
8/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.4%
5/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.4%
8/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
3/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
8/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
15/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
9/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.7%
7/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
8/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
9/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.1%
6/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.4%
2/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.3%
2/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
8/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.4%
8/147 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
9/153 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
2/148 • First dose date up to last dose date (Maximum: 29.3 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER