NCT00484237已完成3 期
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer13 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
研究概览
简要总结
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
详细描述
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
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
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
- •Presence of >6 swollen joints and >6 tender joints
- •Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
- •Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit
排除标准
- •Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
- •Received investigational drugs within 6 months of the baseline visit
- •Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
结局指标
主要结局
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
次要结局
- ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
研究者
研究点 (13)
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