NCT00603512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 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone
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
- 140
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active 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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active rheumatoid arthritis
- •Inadequate response to stably dosed methotrexate
排除标准
- •Current therapy with any DMARD or biologic other than methotrexate
研究组 & 干预措施
CP-690,550, 0mg
Placebo Comparator
干预措施: Placebo (Drug)
CP-690,550, 3mg
Experimental
干预措施: CP-690,550 (Drug)
CP-690,550, 10mg
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, 5mg
Experimental
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 12
时间窗: Week 12
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint 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, 8)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 1, 2, 4, 8, 12/End of Treatment (EOT))
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 1, 2, 4, 8, 12/EOT)
- Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response(Week 1, 2, 4, 8, 12/EOT)
- Tender Joint Count (TJC)(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Swollen Joint Count (SJC)(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Patient Assessment of Arthritis Pain(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Physician Global Assessment (PGA) of Arthritis(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- C-Reactive Protein (CRP)(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Numeric Index of American College of Rheumatology Response (ACR-n)(Week 1, 2, 4, 8, 12/EOT)
- Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 12)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 1, 2, 4, 8, 12/EOT)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Week 1, 2, 4, 8, 12/EOT)
- 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12/EOT)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Baseline, Week 12/EOT)
- Medical Outcome Study- Sleep Scale (MOS-SS)(Baseline, Week 2, 12/EOT)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline, Week 2, 12/EOT)
研究者
研究点 (1)
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