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

Pfizer1 个研究点分布在 1 个国家目标入组 318 人2009年3月

适应症Arthritis, Rheumatoid

干预措施Placebo CP-690,550

概览

阶段: 2 期
干预措施: Placebo
疾病 / 适应症: Arthritis, Rheumatoid
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
状态: 已完成
最后更新: 13年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2009年3月

结束日期

2010年7月

最后更新

13年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Pfizer

责任方

Sponsor

入排标准

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

干预措施: Placebo

CP-690,550, 10mg

干预措施: CP-690,550

CP-690,550, 15mg

干预措施: CP-690,550

CP-690,550, 1mg

干预措施: CP-690,550

CP-690,550, 3mg

干预措施: CP-690,550

CP-690,550, 5mg

干预措施: CP-690,550

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)