A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 26
- 主要终点
- Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active rheumatoid arthritis
- •Incomplete response to methotrexate
排除标准
- •Must not be on biologic therapies
- •No recent infections
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Active
干预措施: CE-224,535 (Drug)
结局指标
主要结局
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Week 12
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
次要结局
- Percentage of Participants With American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 8, 12)
- Patient's Global Assessment of Arthritis(Baseline, Week 2, 4, 8, 12)
- Incidence of Withdrawal Due to Lack of Efficacy(Week 2, 4, 8, 12, 14)
- Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8(Week 2, 4, 8)
- Percentage of Participants With American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 8, 12)
- Number of Tender/Painful and Swollen Joints(Baseline, Week 2, 4, 8, 12)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 2, 4, 8, 12)
- Physician Global Assessment (PGA) of Arthritis(Baseline, Week 2, 4, 8, 12)
- Patient's Global Assessment of Arthritic Pain(Baseline, Week 2, 4, 8, 12)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Week 2, 4, 8, 12)
- C-Reactive Protein (CRP)(Baseline, Week 2, 4, 8, 12)
- Time to Withdrawal Due to Lack of Efficacy(Baseline up to Week 14)