At a glance
ClinicalIndex Comparison Record- ✓Active RA with tender joint count ≥6 (of 68) and swollen joint count ≥6 (of 66) at screening and Day 1
- ✓Inadequate response to oral or parenteral methotrexate 7.5–25 mg/week for at least 12 weeks continuously
- ✓No evidence of active or latent tuberculosis
- ✕Prior B-cell depleting agents (e.g., rituximab) unless >6 months prior and documented return of CD19+ cells at screening
- ✕Any prior treatment with SYK inhibitors (commercial or investigational)
- ✕Concurrent conventional synthetic DMARDs other than methotrexate and/or hydroxychloroquine
- ✕Concurrent biological disease-modifying antirheumatic drugs (bDMARDs); prior bDMARD failure is not exclusionary
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
In Brief
A Phase 2 clinical trial evaluating GS-9876, Filgotinib, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 83 participants across 19 sites in 7 countries.
Detailed Summary
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
Study Details
Timeline
Interventions
One tablet administered orally once daily
Two tablets administered orally once daily
One tablet administered orally once daily
Two tablets administered orally once daily
Background therapy with methotrexate administered orally or parenterally once weekly