NCT00931957Unknown不适用
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
研究概览
简要总结
The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone
详细描述
To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone
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
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
- •Active posterior uveitis and/or retinal vasculitis
排除标准
- •Visual acuity inferior to 1/10 on Snellen chart
- •Being under cytotoxic drugs or having received them in the past 2 months
- •Not being able to follow the one year treatment and the regular follow ups
研究组 & 干预措施
Etanercept-MTX-Prednisolone
Active Comparator
Methotrexate + Prednisolone + Etanercept
干预措施: Etanercept, Methotrexate, Prednisolone (Drug)
B, MTX-Prednisolone
Other
Methotrexate + Prednisolone
干预措施: Etanercept, Methotrexate, Prednisolone (Drug)
结局指标
主要结局
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
时间窗: One Year
次要结局
- DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index(One Year)
研究者
研究点 (1)
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