NCT00393471已完成3 期
A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.
Wyeth is now a wholly owned subsidiary of Pfizer88 个研究点 分布在 11 个国家目标入组 615 人开始时间: 2000年10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
- 615
- 试验地点
- 88
- 主要终点
- The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
研究概览
简要总结
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
详细描述
Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •- Generally healthy of at least 18 years of age with active rheumatoid arthritis.
排除标准
- •- A history or presence of clinically important medical disease.
结局指标
主要结局
The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
次要结局
未报告次要终点
研究者
研究点 (88)
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