A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
研究概览
简要总结
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
排除标准
- •Current Therapy With Any DMARD Or Biologic
研究组 & 干预措施
5 mg BID
CP 690,550 5 mg BID
干预措施: CP-690,550 (Drug)
30 mg BID
Oral tablets administered at a dose of 30 mg BID for 6 weeks
干预措施: CP-690,550 (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
15 mg BID
CP 690,550 15 mg BID
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
时间窗: Week 6
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); 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 Achieving American College of Rheumatology 20% (ACR20) Response(Week 1, 2, 4, and 8)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 1, 2, 4, 6, and 8)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 1, 2, 4, 6, and 8)
- Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 6)
- Tender Joints Count (TJC)(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Swollen Joints Count (SJC)(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Physician Global Assessment of Arthritis(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Patient Assessment of Arthritis Pain(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- C-Reactive Protein (CRP)(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 1, 2, 4, 6, and 8)
- Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8(Baseline, Week 1, 2, 4, 6, and 8)
- Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)(Baseline, Week 1, 2, 4, 6, and 8)