NCT00443950已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
Wyeth is now a wholly owned subsidiary of Pfizer6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年6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
- 150
- 试验地点
- 6
- 主要终点
- The primary endpoint is ACR20 response at 12 weeks.
研究概览
简要总结
The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be of Chinese ancestry and living in China.
- •Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
- •Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.
排除标准
- •Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
结局指标
主要结局
The primary endpoint is ACR20 response at 12 weeks.
次要结局
- Pain visual analog scale(VAS)
- Health assessment questionnaire(HAQ)
- C-reactive protein (CRP) values, Subject global assessments
- Number of tender and swollen joints
- ACR20 (at visit other than week 12)
- ACR50
- ACR70 responses
- Physician global assessments
- Morning stiffness in minutes
研究者
研究点 (6)
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