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临床试验/NCT00413660
NCT00413660已完成2 期

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

Pfizer1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2007年1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
509
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 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults 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
18 Years 至 —（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 5 mg BID

Experimental

干预措施: CP-690,550 (Drug)

CP 690,550 10 mg BID

Experimental

干预措施: CP-690,550 (Drug)

CP 690,550 15 mg

Experimental

干预措施: CP-690,550 (Drug)

CP 690,550 3 mg BID

Experimental

干预措施: CP-690,550 (Drug)

Placebo

Placebo Comparator

Dummy tablets

干预措施: placebo (Other)

CP-690,550 20 mg QD

Experimental

干预措施: CP-690,550 (Drug)

CP 690,550 1 mg BID

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: \>= 20% 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 2, 4, 6, 8, 16, 20, 24/Early Termination (ET))
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve(Baseline up to Week 2, 4, 6, 8, 12)
  • Tender Joints Count (TJC)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Swollen Joints Count (SJC)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Patient Assessment of Arthritis Pain(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Patient Global Assessment (PtGA) of Arthritis(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Physician Global Assessment of Arthritis(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • C-Reactive Protein (CRP)(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 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, 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, 12, 16, 20 and 24/ET(Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 12, 16, 20, 24/ET)
  • Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)(Week 2, 4, 6, 8, 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 Dimentions (EQ-5D) - Health State Profile Utility Score(Baseline, Week 12, 24/ET)
  • Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET(Baseline, Week 12, 24/ET)
  • Medical Outcome Study- Sleep Scale (MOS-SS)(Baseline, Week 2, 12, 24/ET)
  • Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET(Baseline, Week 2, 12, 24/ET)
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Baseline, Week 2, 12, 24/ET)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET(Baseline, Week 2, 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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