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临床试验/NCT01059864
NCT01059864已完成2 期

Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis

Pfizer1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2010年2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
111
试验地点
1
主要终点
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level 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

All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.

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

  • •must be diagnosed as having active rheumatoid arthritis
  • •agree to participate in the study and sign and informed consent document

排除标准

  • •History of serious infection within the past 6 months
  • •test positive for TB
  • •have any uncontrolled clinically significant disease or laboratory tests
  • •require administration of prohibited medications during the study

研究组 & 干预措施

Arm 1

Experimental

干预措施: Atorvastatin (Drug)

Arm 2

Experimental

干预措施: Atorvastatin Placebo (Drug)

Arm 2

Experimental

干预措施: CP-690,550 (Drug)

Arm 1

Experimental

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12

时间窗: Baseline (Week 6), Week 12

次要结局

  • Patient Assessment of Arthritis Pain(Day 0, Week 6 (Baseline), 12)
  • Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12(Baseline (Week 6), Week 12)
  • 12-Hours Fasting Lipid Profile(Day 0, Week 2, 6 (Baseline), 10, 12)
  • 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins(Day 0, Week 2, 6 (Baseline), 10, 12)
  • 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles(Day 0, Week 2, 6 (Baseline), 10, 12)
  • 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles(Day 0, Week 2, 6 (Baseline), 10, 12)
  • Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])(Day 0, Week 6 (Baseline), 12)
  • Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])(Day 0, Week 6 (Baseline), 12)
  • Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])(Day 0, Week 6 (Baseline), 12)
  • Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Day 0, Week 6 (Baseline), 12)
  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Week 6 (Baseline), 12)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 6 (Baseline), 12)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 6 (Baseline), 12)
  • Tender-Joint Count(Day 0, Week 6 (Baseline), 12)
  • Swollen-Joint Count(Day 0, Week 6 (Baseline), Week 12)
  • C-Reactive Protein (CRP)(Day 0, Week 6 (Baseline), 12)
  • Erythrocyte Sedimentation Rate (ESR)(Day 0, Week 6 (Baseline), 12)
  • Physician's Global Assessment (PhysGA) of Arthritis Pain(Day 0, Week 6 (Baseline), Week 12)
  • Patient's Global Assessment (PtGA) of Arthritis Pain(Day 0, Week 6 (Baseline), Week 12)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)(Day 0, Week 6 (Baseline), 12)

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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