Phase 3
Completed N=449
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
Source: ClinicalTrials.gov NCT02873936 ↗Enrolled (actual)
449
Serious AEs
4.2%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 — 66.0; 57.5; 31.1 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
326citations · ~47 / year
Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial.
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 vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial.
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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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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 12 |
66.0; 57.5; 31.1 | <0.001 sig |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 |
1.70; 1.64; 1.65; -0.55; -0.48; -0.23 | <0.001 sig |
| SECONDARY 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; 37.3; 15.5 | <0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 |
30.4; 31.7; 31.1; 7.6; 6.8; 3.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24 |
30.6; 26.1; 12.2 | <0.001 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 |
24.2; 23.7; 25.4; 9.6; 8.3; 4.5 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 |
22.4; 21.6; 7.4; 42.9; 32.0; 14.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 |
6.1; 8.5; 2.7; 21.8; 14.4; 6.8 | 0.16 |
| SECONDARY Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24 |
51.7; 44.4; 25.7; 69.4; 54.9; 34.5 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24 |
28.0; 26.0; 27.0; -13.0; -11.0; -8.0 | 0.003 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24 |
18.0; 17.0; 17.0; -10.0; -7.0; -7.0 | 0.008 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24 |
68.0; 69.0; 70.0; -21.0; -20.0; -10.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24 |
69.0; 68.0; 66.0; -32.0; -30.0; -19.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24 |
66.0; 67.0; 68.0; -22.0; -20.0; -8.0 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24 |
1.70; 1.64; 1.65; -0.39; -0.32; -0.18 | <0.001 sig |
| SECONDARY Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24 |
17.21; 21.49; 16.42; -9.55; -12.15; 1.04 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24 |
60.4; 54.7; 40.3; 66.7; 66.2; 44.4 | <0.001 sig |
| SECONDARY Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24 |
5.9; 5.9; 5.9; -1.7; -1.5; -0.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24 |
21.8; 22.2; 9.5; 48.3; 37.9; 20.9 | 0.004 sig |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12 |
10.2; 11.8; 2.7; 22.4; 25.5; 8.1 | 0.012 sig |
| SECONDARY American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24 |
26.9; 25.8; 13.7; 43.4; 37.1; 19.7 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24 |
32; 34; 13; 74; 65; 53 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24 |
41.7; 40.4; 41.4; -19.1; -16.8; -12.8 | <0.001 sig |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24 |
43.4; 42.6; 43.0; -20.1; -18.1; -12.9 | <0.001 sig |
| SECONDARY SF-36 PCS Score at Weeks 4, 12, and 24 |
35.4; 36.4; 33.7; 38.3; 38.6; 35.1 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 |
30.4; 31.7; 31.1; 5.1; 4.5; 2.5 | <0.001 sig |
| SECONDARY SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 |
48.0; 47.3; 45.5; 50.2; 48.8; 47.9 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 |
44.5; 44.2; 44.3; 3.5; 3.0; 1.2 | 0.019 sig |
| SECONDARY FACIT-Fatigue Score at Weeks 4, 12, and 24 |
30.4; 30.3; 27.9; 34.0; 32.1; 30.4 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 |
24.2; 23.7; 25.4; 6.2; 6.4; 2.2 | <0.001 sig |
| SECONDARY Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 |
34; 45; 32; 58; 49; 49 | — |
| SECONDARY EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
59.0; 60.0; 52.0; 66.0; 65.0; 58.0 | — |
| SECONDARY Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 |
49.0; 46.0; 46.0; 10.0; 14.0; 6.0 | 0.009 sig |
| SECONDARY Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
8.8; 18.2; 14.3; 5.6; 14.6; 12.1 | — |
| SECONDARY WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
27.4; 37.8; 48.6; 23.9; 34.8; 44.2 | — |
| SECONDARY WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
30.8; 43.1; 51.3; 26.9; 39.5; 46.9 | — |
| SECONDARY WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
49.6; 49.9; 60.3; 40.3; 45.5; 53.0 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 |
11.3; 19.2; 10.8; -4.3; -3.4; 4.0 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 |
46.9; 51.0; 55.7; -19.1; -13.1; -5.3 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 |
52.0; 55.8; 56.7; -20.9; -12.3; -3.4 | — |
| SECONDARY Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 |
65.6; 64.6; 65.4; -16.0; -14.3; -4.7 | — |
Eligibility Criteria
Key Inclusion Criteria
- Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria for RA), and are ACR functional class I-III.
- Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) and ≥6 tender joints (from a tender joint count based on 68 joints [TJC68]) at screening and Day 1
- Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
- Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance
Key Exclusion Criteria
- Previous treatment with any janus kinase (JAK) inhibitor
NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02873936) 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.