Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 399
- 试验地点
- 1
- 主要终点
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
研究概览
简要总结
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
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
- •Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
排除标准
- •Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
研究组 & 干预措施
Sequence 1
干预措施: CP-690,550 (Drug)
Sequence 3
干预措施: Placebo (Drug)
Sequence 3
干预措施: CP-690,550 (Drug)
Sequence 4
干预措施: Placebo (Drug)
Sequence 4
干预措施: CP-690,550 (Drug)
Sequence 2
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
时间窗: Baseline, Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
时间窗: Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
时间窗: Month 3
ACR20 response: greater than or equal to (\>=) 20 percent (%) 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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
次要结局
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6(Month 4.5, 6)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6(Month 4.5, 6)
- Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1(Week 2, Month 1)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3(Week 2, Month 1, 3)
- Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- Physician Global Assessment of Arthritis at Month 4.5 and 6(Month 4.5, 6)
- Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3(Baseline, Month 3)
- Number of Hours Per Day as Assessed RA-HCRU at Month 6(Month 6)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3(Baseline, Month 3)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6(Month 6)
- Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3(Baseline, Month 3)
- Work Limitations Questionnaire (WLQ) Score at Month 6(Month 6)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6(Month 4.5, 6)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3(Week 2, Month 1, 3)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6(Month 4.5 and 6)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3(Week 2, Month 1, 3)
- Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3(Baseline, Month 3)
- Patient Assessment of Arthritis Pain at Month 4.5 and 6(Month 4.5, 6)
- 36-Item Short-Form Health Survey (SF-36) at Month 6(Month 6)
- Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6(Month 6)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3(Baseline, Week 2, Month 1, 3)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6(Month 6)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3(Baseline, Week 2, Month 1, 3)
- Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6(Month 6)
- Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6(Month 4.5, 6)
- Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6(Month 4.5, 6)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6(Month 6)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3(Baseline, Month 3)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6(Month 6)
- Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6(Month 6)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3(Baseline, Month 3)
- Number of Days as Assessed Using RA-HCRU at Baseline and Month 3(Baseline, Month 3)
- Number of Days as Assessed Using RA-HCRU at Month 6(Month 6)
- Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3(Baseline, Month 3)
- Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3(Baseline, Month 1, 3)
- Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6(Month 6)