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
Overview
- Phase
- Phase 2
- Intervention
- GS-9876 placebo
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Gilead Sciences
- Enrollment
- 83
- Locations
- 19
- Primary Endpoint
- Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
Intervention: GS-9876 placebo
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
Intervention: GS-9876
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
Intervention: Filgotinib placebo
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
Intervention: Methotrexate
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
Intervention: GS-9876
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
Intervention: Filgotinib placebo
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
Intervention: Methotrexate
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
Intervention: Filgotinib
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
Intervention: Methotrexate
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
Intervention: GS-9876 placebo
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
Intervention: Filgotinib placebo
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
Intervention: Methotrexate
Outcomes
Primary Outcomes
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
Time Frame: Baseline; Week 12
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Secondary Outcomes
- Percentage of Participants Who Achieved ACR50 Improvement at Week 12(Week 12)
- Percentage of Participants Who Achieved ACR70 Improvement at Week 12(Week 12)
- Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12(Baseline; Week 12)
- Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12(Week 12)