A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With 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
- 209
- 试验地点
- 36
- 主要终点
- Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
研究概览
简要总结
This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of rheumatoid arthritis
- •currently taking a stable dose of methotrexate
- •no evidence of active or latent or inadequately treated tuberculosis
排除标准
- •evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
- •clinically significant infections within the past 6 months
研究组 & 干预措施
tofacitinib modified release tablet
干预措施: Tofacitinib (Drug)
tofacitinib immediate release tablet
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
时间窗: Baseline, Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter \[mg/L\]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \[less than or equal to\] \<= 3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 implied remission.
次要结局
- Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12(Week 12)
- Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12(Baseline, Week 12)
- Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12(Week 12)
- Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12(Baseline, Week 12)
- Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12(Week 12)
- Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12(Week 12)
- Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12(Week 12)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12(Baseline, Week 12)
- Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12(Week 12)
- Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12(Baseline, Week 12)
- Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12(Week 12)
- Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12(Week 12)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12(Baseline, Week 12)
- Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12(Baseline, Week 12)