NCT00247962已完成4 期
A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 566 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 566
- 主要终点
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
研究概览
简要总结
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
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 (Participant, Investigator)
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
- •Clinical diagnosis of ankylosing spondylitis
- •Active ankylosing spondylitis
排除标准
- •Complete ankylosis of spine
- •Previous treatment with etanercept
研究组 & 干预措施
A
Experimental
干预措施: etanercept (Drug)
B
Active Comparator
干预措施: sulphasalazine (SSZ) (Drug)
结局指标
主要结局
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
时间窗: 16 weeks
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
次要结局
- Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline(Baseline and 16 Weeks)
研究者
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