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临床试验/NCT00661661
NCT00661661已完成3 期

A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis

Pfizer56 个研究点 分布在 1 个国家目标入组 487 人开始时间: 2008年4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
3 期
状态
已完成
发起方
Pfizer
入组人数
487
试验地点
56
主要终点
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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 long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

排除标准

  • •Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

研究组 & 干预措施

CP-690,550

Experimental

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

时间窗: Baseline up to Week 288

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.

次要结局

  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Patient Global Assessment of Arthritis(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Physician Global Assessment of Arthritis(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Patient Assessment of Arthritis Pain(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Tender/Painful Joint Counts(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in Swollen Joint Counts(Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)
  • Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)(First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96)
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental(Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (56)

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