A 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 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 was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: etanercept (Drug)
2
干预措施: etanercept/placebo (Drug)
结局指标
主要结局
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.
时间窗: 12 weeks
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 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
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.(12 weeks)
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.(12 weeks)
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.(12 weeks)
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.(12 weeks)
- Number of Patients Achieving Partial Remission.(12 weeks)
- Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.(Baseline and 12 weeks)
- Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.(Baseline and 12 weeks)
- Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.(Baseline and 12 weeks)
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.(Baseline and 12 weeks)
- Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.(Baseline and 12 weeks)
- Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.(Baseline and 12 weeks)
- Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire(12 weeks)
- Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.(Baseline and 12 weeks)
- Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms(12 weeks)
- Change in C-reactive Protein (CRP) From Baseline to Week 12.(Baseline and 12 weeks)