NCT00233571已完成3 期
A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)
Abbott0 个研究点目标入组 796 人开始时间: 2000年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 796
- 主要终点
- Clinical response indicators
研究概览
简要总结
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completion of a previous D2E7 study
- •Subject is in good health (Investigator discretion) with a recent stable medical history
排除标准
- •Former enrollment in this trial (DE018)
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Female subject who is pregnant or breast feeding or considering becoming pregnant.
研究组 & 干预措施
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Experimental
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
干预措施: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) (Biological)
结局指标
主要结局
Clinical response indicators
时间窗: 5 years
次要结局
- Safety parameters(5 years)
研究者
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