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临床试验/NCT00550446
NCT00550446已完成2 期

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Pfizer1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2007年9月最近更新:
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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
386
试验地点
1
主要终点
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects must have active rheumatoid arthritis
  • •Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
  • •Subjects must not be currently taking any DMARD other than an antimalarial

排除标准

  • •Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
  • •Subjects who previously received adalimumab (Humira®) therapy for any reason.
  • •Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

研究组 & 干预措施

1

Active Comparator

干预措施: Adalimumab (Drug)

6

Experimental

干预措施: CP-690,550 (Drug)

7

Placebo Comparator

干预措施: Placebo (Drug)

2

Experimental

干预措施: CP-690-550 (Drug)

3

Experimental

干预措施: CP-690-550 (Drug)

4

Experimental

干预措施: CP-690-550 (Drug)

5

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 % 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

  • Patient Global Assessment (PtGA) of Arthritis Pain(Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET))
  • Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 2, 4, 6, 8, 10, 12)
  • Tender Joint Count (TJC)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Swollen Joint Counts (SJC)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Patient Assessment of Arthritis Pain(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET)
  • Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Physician Global Assessment (PGA) of Arthritis(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • C-Reactive Protein (CRP)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
  • Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET)
  • Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
  • Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET)
  • 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 12, 24/ ET)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET(Baseline, Week 12, 24/ ET)
  • Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score(Baseline, Week 12, 24/ ET)
  • Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET(Baseline, Week 12, 24/ ET)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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