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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 19
- 主要终点
- Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
干预措施: GS-9876 placebo (Drug)
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
干预措施: GS-9876 (Drug)
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
干预措施: Filgotinib placebo (Drug)
GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
干预措施: Methotrexate (Drug)
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
干预措施: GS-9876 (Drug)
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
干预措施: Filgotinib placebo (Drug)
GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
干预措施: Methotrexate (Drug)
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
干预措施: Filgotinib (Drug)
Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
干预措施: Methotrexate (Drug)
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
干预措施: GS-9876 placebo (Drug)
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
干预措施: Filgotinib placebo (Drug)
Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
时间窗: 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.
次要结局
- 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)