Phase 3
Completed N=1,759
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT02889796 ↗Enrolled (actual)
1,759
Serious AEs
6.2%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 — 76.6; 69.8; 70.5; 49.9 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
10citations · ~3 / year
Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis.
Summary
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
Linked Publications (5)
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Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis.
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Patients with High Baseline Neutrophil-to-Lymphocyte Ratio Exhibit Better Response to Filgotinib as Treatment for Rheumatoid Arthritis.
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Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis.
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Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate.
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The Uncoupling of Disease Activity from Joint Structural Progression in Patients with Rheumatoid Arthritis Treated with Filgotinib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 |
76.6; 69.8; 70.5; 49.9 | <0.001 sig |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 |
1.59; 1.55; 1.59; 1.63; -0.69; -0.56 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 |
34.1; 23.8; 23.7; 9.3 | <0.001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 |
32.47; 36.70; 34.82; 31.60; 0.13; 0.17 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 |
49.7; 38.8; 43.4; 23.4 | <0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 |
33.4; 33.6; 32.8; 32.9; 9.2; 8.5 | <0.001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 |
27.6; 27.8; 27.2; 26.9; 9.2; 9.1 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 |
9.1; 5.8; 6.8; 1.1; 22.3; 12.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 |
63.2; 57.7; 57.5; 67.9; 63.4; 64.2 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 |
2.7; 1.3; 0.9; 0.4; 9.1; 3.3 | 0.008 sig |
| SECONDARY Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 |
40.2; 35.4; 32.9; 44.7; 34.6; 44.4 | — |
| SECONDARY Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 |
37.3; 27.5; 33.5; 14.9; 51.6; 45.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 |
82.9; 79.2; 76.3; 90.5; 86.9; 82.9 | — |
| SECONDARY Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 |
1.59; 1.55; 1.59; 1.63; -0.30; -0.22 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 |
1.59; 1.55; 1.59; 1.68; 1.58; -0.88 | — |
| SECONDARY Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 |
25; 25; 24; 24; -8; -7 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 |
25; 25; 24; 25; 24; -21 | — |
| SECONDARY Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 |
15; 15; 16; 16; -6; -5 | 0.002 sig |
| SECONDARY Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 |
15; 15; 16; 16; 15; -14 | — |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 |
67; 65; 67; 68; -16; -11 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 |
67; 65; 67; 70; 66; -42 | — |
| SECONDARY Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 |
66; 65; 67; 66; -20; -18 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 |
66; 65; 67; 68; 64; -51 | — |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 |
65; 64; 64; 66; -16; -12 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 |
65; 64; 64; 68; 65; -40 | — |
| SECONDARY Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 |
16.13; 16.74; 14.56; 16.25; -10.85; -7.67 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 |
16.13; 16.74; 14.56; 16.54; 15.76; -11.51 | — |
| SECONDARY Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 |
52.5; 46.7; 51.9; 40.2; 66.2; 58.0 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 |
77.1; 74.9; 71.5; 83.2; 77.7; 75.8 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 |
5.8; 5.7; 5.7; 5.7; -1.3; -1.0 | <0.001 sig |
| SECONDARY Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 |
5.8; 5.7; 5.7; 5.9; 5.6; -3.2 | — |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 |
13.1; 8.1; 9.8; 3.6; 25.5; 20.4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 |
67.4; 60.2; 58.2; 74.7; 66.5; 68.2 | — |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 |
5.1; 1.7; 3.4; 0.6; 13.7; 8.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 |
50.3; 42.9; 42.5; 52.1; 46.1; 54.5 | — |
| SECONDARY American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 |
18.3; 14.0; 16.3; 8.0; 27.4; 23.0 | — |
| SECONDARY ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 |
62.5; 59.1; 58.6; 63.2; 56.1; 66.0 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 |
58; 32; 27; 15; 237; 213 | — |
| SECONDARY Number of Participants With EULAR Response at Weeks 36, and 52 |
306; 276; 180; 139; 124; 99 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 |
39.5; 38.6; 39.2; 39.6; -12.7; -10.7 | <0.001 sig |
| SECONDARY Change From Baseline in CDAI at Weeks 36, and 52 |
39.5; 38.6; 39.2; 41.4; 37.8; -32.1 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 |
41.2; 40.2; 40.6; 41.2; -14.0; -11.4 | <0.001 sig |
| SECONDARY Change From Baseline in SDAI at Weeks 36, and 52 |
41.2; 40.2; 40.6; 43.0; 39.4; -33.3 | — |
| SECONDARY Change From Baseline in mTSS at Week 52 |
32.62; 36.24; 33.94; 26.68; 32.38; 0.21 | 0.042 sig |
| SECONDARY Percentage of Participants With no Radiographic Progression From Baseline at Week 24 |
93.8; 91.1; 91.9; 87.2; 87.9; 85.9 | 0.002 sig |
| SECONDARY Percentage of Participants With no Radiographic Progression From Baseline at Week 52 |
92.1; 87.1; 88.6; 83.9; 83.7; 87.5 | — |
| SECONDARY 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 |
39.0; 38.2; 37.7; 36.1; 42.7; 42.1 | — |
| SECONDARY SF-36 PCS Score at Weeks 36, and 52 |
45.2; 44.4; 43.8; 45.2; 43.2; 45.6 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 |
33.4; 33.6; 32.8; 32.9; 5.6; 4.6 | <0.001 sig |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 |
33.4; 33.6; 32.8; 32.2; 33.7; 11.6 | — |
| SECONDARY SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 |
47.8; 47.9; 47.9; 45.8; 49.3; 49.9 | — |
| SECONDARY SF-36 MCS Score at Weeks 36, and 52 |
50.1; 51.3; 50.7; 50.7; 50.3; 50.6 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 |
43.9; 44.6; 44.1; 43.4; 3.9; 3.4 | <0.001 sig |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 |
43.9; 44.6; 44.1; 43.9; 43.4; 6.2 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 |
33.9; 33.3; 32.9; 30.9; 36.8; 36.7 | — |
| SECONDARY FACIT-Fatigue Score at Weeks 36, and 52 |
38.9; 39.5; 38.6; 39.6; 37.4; 39.8 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 |
27.6; 27.8; 27.2; 26.9; 6.3; 5.7 | <0.001 sig |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 |
27.6; 27.8; 27.2; 26.8; 27.9; 11.0 | — |
| SECONDARY Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 |
130; 129; 84; 100; 176; 173 | — |
| SECONDARY Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 |
202; 189; 122; 86; 78; 121 | — |
| SECONDARY EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
59; 59; 60; 56; 66; 66 | — |
| SECONDARY EQ-5D Current Health VAS at Weeks 36, and 52 |
69; 72; 67; 73; 71; 72 | — |
| SECONDARY Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
48; 49; 47; 46; 11; 10 | 0.049 sig |
| SECONDARY Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 |
48; 49; 47; 45; 47; 21 | — |
| SECONDARY Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
8.5; 6.6; 9.2; 9.4; 6.6; 5.4 | — |
| SECONDARY WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 |
5.5; 7.7; 7.0; 6.8; 8.4; 4.8 | — |
| SECONDARY WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
34.3; 36.9; 35.6; 42.5; 26.3; 26.9 | — |
| SECONDARY WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 |
20.2; 19.6; 21.2; 21.5; 25.8; 18.2 | — |
| SECONDARY WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
37.0; 39.5; 38.4; 45.1; 29.5; 29.3 | — |
| SECONDARY WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 |
23.3; 23.9; 23.8; 24.0; 29.1; 20.6 | — |
| SECONDARY WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
44.6; 46.2; 46.4; 52.1; 35.1; 36.6 | — |
| SECONDARY WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 |
28.3; 28.7; 31.3; 28.3; 32.3; 26.0 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
12.0; 9.9; 16.0; 17.0; -1.4; -2.1 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 |
12.0; 9.9; 16.0; 18.3; 14.6; -4.4 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
49.1; 48.0; 50.8; 52.5; -15.1; -10.2 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 |
49.1; 48.0; 50.8; 53.8; 53.6; -29.7 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
51.3; 50.6; 54.3; 55.8; -14.6; -10.2 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 |
51.3; 50.6; 54.3; 56.6; 57.1; -28.9 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
61.5; 60.5; 61.3; 62.2; -17.0; -14.7 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 |
61.5; 60.5; 61.3; 62.9; 59.7; -32.6 | — |
Eligibility Criteria
Key Inclusion Criteria
- Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria] , and are ACR functional class I-III.
- Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
- Ongoing treatment with a stable dose of MTX
Key Exclusion Criteria
- Previous treatment with any janus kinase (JAK) inhibitor
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02889796) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.