Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
研究概览
简要总结
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
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
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 2
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)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
时间窗: Month 6
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; 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 6 analysis.
Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
时间窗: Baseline, Month 6
mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
时间窗: Month 6
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated 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 and less than (\<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
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 and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores 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.
次要结局
- Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3(Month 1, 3)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6(Month 1, 3, 6)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6(Month 1, 3, 6)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24(Month 12, 18, 24)
- Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 1, 3, 6)
- Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24(Month 12, 18, 24)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])(Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])(Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24)
- Modified Total Sharp Scores (mTSS) at Baseline(Baseline)
- Modified Total Sharp Scores (mTSS) at Month 12 and 24(Month 12, 24)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6(Baseline, Month 1, 3, 6)
- Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24(Month 9, 12, 15, 18, 21, 24)
- Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6(Baseline, Month 1, 3, 6)
- Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24(Month 12, 18, 24)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24(Month 12, 18, 24)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6(Baseline, Month 1, 3, 6)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24(Month 12, 18, 24)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24(Month 12, 18, 24)
- Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24(Month 12, 18, 24)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24(Month 12, 18, 24)
- Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24(Month 12, 18, 24)
- Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 1, 3, 6)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 1, 3, 6)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24(Month 12, 18, 24)