Phase 3
Completed N=1,252
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Source: ClinicalTrials.gov NCT02886728 ↗Enrolled (actual)
1,252
Serious AEs
6.7%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 — 81.0; 80.2; 78.1; 71.4 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 in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
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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Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials.
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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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Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 |
81.0; 80.2; 78.1; 71.4 | <0.001 sig |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 |
1.52; 1.56; 1.56; 1.60; -0.94; -0.90 | <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 24 |
54.1; 42.5; 42.4; 29.1 | <0.001 sig |
| SECONDARY Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 |
11.35; 13.31; 16.53; 13.72; 0.21; 0.22 | 0.068 |
| SECONDARY Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 |
33.9; 33.7; 33.6; 33.3; 12.3; 11.1 | <0.001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 |
28.3; 27.3; 27.3; 27.1; 10.6; 11.4 | 0.056 |
| SECONDARY Change From Baseline in the mTSS at Week 52 |
11.31; 12.76; 15.89; 13.36; 0.31; 0.23 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 |
42.1; 37.2; 39.5; 16.6; 62.3; 55.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 |
13.0; 9.2; 16.2; 2.9; 29.3; 20.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 |
3.1; 1.9; 4.3; 0.7; 13.0; 6.3 | 0.018 sig |
| SECONDARY Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 |
1.52; 1.56; 1.56; 1.60; -0.37; -0.36 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 |
26; 25; 26; 26; -9; -8 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 |
16.0; 16.0; 16.0; 16.0; -7.0; -6.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 |
65.0; 66.0; 68.0; 66.0; -17.0; -13.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 |
66.0; 68.0; 66.0; 67.0; -24.0; -21.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 |
64.0; 67.0; 67.0; 66.0; -18.0; -15.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 |
18.04; 17.72; 17.32; 16.86; -12.89; -9.40 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 |
61.9; 58.5; 53.9; 42.2; 72.4; 61.0 | <0.001 sig |
| SECONDARY Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 |
5.7; 5.7; 5.8; 5.7; -1.3; -1.1 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 |
30.8; 23.7; 31.9; 12.0; 55.8; 50.2 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 |
7.2; 4.3; 10.0; 1.0; 16.6; 15.0 | <0.001 sig |
| SECONDARY ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 |
20.8; 17.8; 20.9; 8.9; 34.1; 27.6 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 |
66; 21; 35; 20; 199; 92 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 |
39.5; 39.2; 40.0; 40.2; -13.6; -12.0 | <0.001 sig |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 |
41.3; 41.0; 41.8; 41.9; -14.9; -12.9 | <0.001 sig |
| SECONDARY Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 |
89.6; 87.0; 89.6; 82.0; 80.6; 76.6 | 0.006 sig |
| SECONDARY SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 |
40.6; 39.2; 39.6; 37.0; 45.0; 42.9 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 |
33.9; 33.7; 33.6; 33.3; 6.8; 5.3 | <0.001 sig |
| SECONDARY SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 |
48.7; 46.9; 47.5; 45.5; 49.9; 49.2 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 |
44.6; 43.2; 43.1; 43.5; 4.1; 3.6 | <0.001 sig |
| SECONDARY FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 |
35.2; 34.1; 34.2; 31.4; 38.1; 36.6 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 |
28.3; 27.3; 27.3; 27.1; 7.0; 6.7 | <0.001 sig |
| SECONDARY Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 |
161; 66; 81; 104; 149; 68 | — |
| SECONDARY EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 |
65; 61; 62; 56; 69; 67 | — |
| SECONDARY Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 |
50; 50; 51; 50; 16; 10 | <0.001 sig |
| SECONDARY Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 |
10.1; 15.4; 9.2; 16.0; 6.7; 7.3 | — |
| SECONDARY WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 |
29.6; 29.4; 33.9; 45.3; 22.6; 23.6 | — |
| SECONDARY WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 |
32.8; 32.3; 37.0; 48.6; 25.1; 26.7 | — |
| SECONDARY WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 |
40.4; 46.8; 45.4; 51.6; 30.6; 36.1 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 |
12.8; 20.1; 13.5; 15.6; -1.5; -3.3 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 |
47.3; 49.0; 52.1; 53.6; -17.8; -19.8 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 |
50.8; 51.6; 54.4; 56.1; -17.6; -19.0 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 |
60.2; 62.8; 63.3; 64.0; -19.9; -15.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Have a diagnosis of 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.
- Limited or no prior treatment with MTX
Key Exclusion Criteria
- Previous treatment with any janus kinase (JAK) inhibitor
- Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
- Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02886728) 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.