NCT00444340已完成4 期
An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 70 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
研究概览
简要总结
This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.
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
- •Completed study 0881A3-312-EU
- •Agreeable to utilize medically acceptable form of contraception
- •Able to reconstitute and self-inject or have a designee
排除标准
- •Withdrawn from study 0881A3-312-EU
- •Abnormal hematology or chemistry profiles
- •Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection
结局指标
主要结局
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
次要结局
- To assess the long-term clinical efficacy of etanercept in these study subjects.
研究者
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