NCT00421915已完成3 期
Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 84 人开始时间: 2002年3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
- 84
- 主要终点
- To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
研究概览
简要总结
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.
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
- •Main inclusion criteria
- •Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
- •Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30 for duration and intensity of morning stiffness and by 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).
- •18 to 70 years of age.
排除标准
- •Complete ankylosis (fusion) of spine.
- •Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors.
- •Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
结局指标
主要结局
To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
次要结局
- To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
- compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
研究者
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