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
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
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
研究点 (1)
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