Phase 2
Completed N=83
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Source: ClinicalTrials.gov NCT02885181 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 — -1.26; -0.78; -2.46; -1.36 units on a scale — p=0.978
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 |
-1.26; -0.78; -2.46; -1.36 | 0.978 |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 |
35.0; 25.0; 81.0; 40.9 | 0.660 |
| SECONDARY Percentage of Participants Who Achieved ACR50 Improvement at Week 12 |
20.0; 20.0; 47.6; 22.7 | 0.853 |
| SECONDARY Percentage of Participants Who Achieved ACR70 Improvement at Week 12 |
5.0; 15.0; 38.1; 13.6 | 0.360 |
| SECONDARY Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 |
-0.46; -0.18; -0.70; -0.39 | 0.528 |
Eligibility Criteria
Key Inclusion Criteria
- Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1
- Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks
- No evidence of active or latent tuberculosis
Key Exclusion Criteria
- Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
- Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
- Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
- Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02885181). 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.