NCT00445770已完成3 期
A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
研究概览
简要总结
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be Japanese and live in Japan
- •Must be age 20 to 75 years
- •Diagnosed less than or equal to 10 years from time of first visit
排除标准
- •Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
- •Patient with other rheumatic diseases or conditions that could predispose the patient to infection
- •Pregnant or lactating women
研究组 & 干预措施
1
Experimental
干预措施: Etanercept (Drug)
2
Experimental
干预措施: Etanercept (Drug)
3
Active Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
时间窗: Week 52
mTSS = sum of erosion and 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 represents improvement.
次要结局
- Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52(Baseline, Week 24, and Week 52)
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Percentage of Participants With no Progression of Joint Destruction at Week 52(Baseline and Week 52)
- Percentage of Participants With an ACR70 Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24(Week 24)
- Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Erosion Score at Weeks 24 and 52(Baseline, Week 24, and Week 52)
- Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Percentage of Participants With an ACR50 Response(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
研究者
研究点 (1)
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