Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 611
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
研究概览
简要总结
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe 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 RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- •The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory.
- •CRP >7 mg/L in the central laboratory
- •Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
- •No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- •Patient has washed out of all DMARDs other that antimalarials
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 autoimmune rheumatic 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
Active 5mg
干预措施: CP-690,550 (Drug)
Active 10 mg
干预措施: CP-690,550 (Drug)
Placebo Sequence 1
干预措施: Placebo (Drug)
Placebo Sequence 2
干预措施: Placebo (Drug)
结局指标
主要结局
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 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).
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 functional 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 from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
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 3
时间窗: Month 3
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.
次要结局
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2(Week 2, Month 1, 2)
- 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, 2 and 3(Week 2, Month 1, 2, 3)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6(Month 4, 5, 6)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3(Week 2, Month 1, 2, 3)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6(Month 4, 5, 6)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3(Baseline, Month 3)
- Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6(Month 6)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3(Baseline, Week 2, Month 1, 2, 3)
- Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6(Month 4, 5, 6)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3(Baseline, Week 2, Month 1, 2, 3)
- Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6(Month 4, 5, 6)
- Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3(Baseline, Week 2, Month 1, 2, 3)
- Patient Assessment of Arthritis Pain at Month 4, 5 and 6(Month 4, 5, 6)
- Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3(Baseline, Week 2, Month 1, 2, 3)
- Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6(Month 4, 5, 6)
- Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3(Baseline, Week 2, Month 1, 2, 3)
- Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6(Month 4, 5, 6)
- 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3(Baseline, Month 3)
- 36-Item Short-Form Health Survey (SF-36) at Month 6(Month 6)
- Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3(Baseline, Month 3)
- Number of Days as Assessed Using RA-HCRU at Baseline and Month 3(Baseline, Month 3)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3(Baseline, Month 3)
- Medical Outcome 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 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 (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3(Baseline, Month 3)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6(Month 6)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3(Baseline, Month 3)
- Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6(Month 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 Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6(Month 6)
- 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)
- Number of Hours Per Days as Assessed Using 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)