Phase 2
Completed N=739
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
Source: ClinicalTrials.gov NCT02065700 ↗Enrolled (actual)
739
Serious AEs
17.9%
Results posted
Jun 2024
Primary outcomePrimary: Number of Participants Experiencing Treatment-Emergent Adverse Events — 453; 223 participants
Summary
The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.
Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment-Emergent Adverse Events |
453; 223 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI) |
76.5; 77.3; 83.9; 83.1; 75.3; 77.7 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response: Observed Case (OC) |
77.4; 79.6; 86.2; 87.4; 84.8; 89.5 | — |
| SECONDARY Percentage of Participants Achieving ACR50 Response: NRI |
48.5; 45.0; 60.8; 61.2; 56.7; 60.3 | — |
| SECONDARY Percentage of Participants Achieving ACR50 Response: OC |
49.4; 46.4; 62.4; 64.1; 64.1; 69.2 | — |
| SECONDARY Percentage of Participants Achieving ACR70 Response: NRI |
30.0; 23.1; 36.8; 36.4; 37.8; 39.3 | — |
| SECONDARY Percentage of Participants Achieving ACR70 Response: OC |
30.3; 23.5; 37.7; 38.1; 42.7; 45.0 | — |
| SECONDARY ACR N% Improvement (ACR-N) Response: OC |
48.1; 46.3; 56.3; 56.3; 57.9; 60.8 | — |
| SECONDARY Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC |
-2.7; -2.6; -3.1; -3.1; -3.2; -3.2 | — |
| SECONDARY Change From Core Baseline in Simple Disease Activity Index (SDAI): OC |
-30.2; -29.8; -33.4; -34.1; -34.0; -35.0 | — |
| SECONDARY Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC |
-28.8; -28.0; -31.8; -32.4; -32.4; -32.9 | — |
| SECONDARY Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC |
46.2; 41.5; 43.6; 48.7; 10.2; 9.8 | — |
| SECONDARY Percentage of Participants Achieving ACR/EULAR Remission: NRI |
10.1; 7.4; 13.1; 11.6; 14.9; 15.3 | — |
| SECONDARY Percentage of Participants Achieving ACR/EULAR Remission: OC |
10.1; 7.5; 13.3; 11.9; 16.6; 17.2 | — |
| SECONDARY Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC |
9.2; 9.5; 11.3; 11.5; 12.2; 11.8 | — |
| SECONDARY Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC |
6.1; 7.1; 6.2; 6.8; 6.5; 6.7 | — |
| SECONDARY Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC |
10.7; 12.1; 11.6; 12.7; 12.0; 12.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment
- Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib
Key Exclusion Criteria
- Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason
- Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment
- Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome
- Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02065700). 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.