NCT00418548已完成3 期
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 350 人开始时间: 2004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
- 350
- 主要终点
- The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
研究概览
简要总结
The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- •Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
排除标准
- •Complete ankylosis (fusion) of spine.
- •Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents.
- •Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
- •Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
- •Dose of NSAID changed within 2 weeks of baseline evaluation.
- •Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
结局指标
主要结局
The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
次要结局
未报告次要终点
研究者
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