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 DMARDS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 795
- 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 Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
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
- •The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
- •The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
- •Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
- •Patient must remain on at least one background traditional disease modifying antirheumatic drug.
- •No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
排除标准
- •Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
- •History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
- •No malignancy or history of malignancy.
- •History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.
研究组 & 干预措施
Placebo Sequence 1
Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
干预措施: Placebo (Drug)
Placebo Sequence 2
Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
干预措施: Placebo (Drug)
Active 5 mg
干预措施: CP-690,550 (Drug)
Active 10 mg
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 (TJC); \>= 20% improvement in swollen joint 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 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;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 Achieving 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) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/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 6 analysis.
次要结局
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6(Week 2, Month 1, 2, 3, 4.5, 6)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12(Month 9, 12)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6(Week 2, Month 1, 2, 3, 4.5, 6)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12(Month 9, 12)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6(Week 2, Month 1, 2, 3, 4.5, 6)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12(Month 9, 12)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6(Week 2, Month 1, 2, 3, 4.5, 6)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12(Month 9, 12)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12(Month 12)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])(Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])(Baseline, Month 3, 6, 12)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6(Baseline, Week 2, Month 1, 2, 3, 4.5, 6)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12(Month 9, Month 12)
- Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6(Baseline, Week 2, Month 1, 2, 3, 4.5, 6)
- Patient Assessment of Arthritis Pain at Month 9 and 12(Month 9, 12)
- Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6(Baseline, Week 2, Month 1, 2, 3, 4.5, 6)
- Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12(Month 9, 12)
- Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6(Baseline, Week 2, Month 1, 2, 3, 4.5, 6)
- Physician Global Assessment (PGA) of Arthritis at Month 9 and 12(Month 9, 12)
- 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 and 12(Month 9, 12)
- 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 Outcome Study (MOS) Sleep Scale at Month 12(Month 12)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12(Month 12)
- 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(Month 12)
- 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(Month 12)
- Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Work Limitations Questionnaire (WLQ) Score at Month 12(Month 12)
- 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(Month 12)
- 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(Month 12)
- Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Number of Days as Assessed Using RA-HCRU at Month 12(Month 12)
- Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Number of Hours Per Day as Assessed RA-HCRU at Month 12(Month 12)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6(Baseline, Month 3, 6)
- Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12(Month 12)