NCT00687193已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.
排除标准
- •Current therapy with any DMARD
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CP-690,550, 15mg
Experimental
干预措施: CP-690,550 (Drug)
CP-690,550, 1mg
Experimental
干预措施: CP-690,550 (Drug)
CP-690,550, 3mg
Experimental
干预措施: CP-690,550 (Drug)
CP-690,550, 5mg
Experimental
干预措施: CP-690,550 (Drug)
CP-690,550, 10mg
Experimental
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Week 12
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in painful and 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
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8(Week 2, 4, and 8)
- Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 8 and 12)
- Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 8 and 12)
- Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response(Week 2, 4, 8 and 12)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)](Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)](Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Painful and Tender Joint Counts(Baseline, Weeks 2, 4, 8 and 12)
- Change From Baseline in Swollen Joint Count (SJC)(Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Patient's Assessment of Pain(Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Patient's Global Assessment of Arthritis(Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in Physician's Global Assessment of Arthritis(Baseline, Week 2, 4, 8 and 12)
- Change From Baseline in C- Reactive Protein (CRP) (mg/L)(Baseline, Week 2, 4, 8 and 12)
- Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)(Baseline, Week 12)
- Change From Baseline in Euro Quality of Life (EQ-5D)(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)(Baseline, Week 12)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)(Baseline, Week 12)
研究者
研究点 (1)
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