临床试验/NCT00664599

NCT00664599已完成2 期

Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Tehran University of Medical Sciences1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2006年4月最近更新: 2008年4月30日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Tehran University of Medical Sciences
入组人数: 20
试验地点: 1
主要终点: Visual acuity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

详细描述

To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily 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 (Outcomes Assessor)

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
•Having active ocular lesions (posterior and/or retinal vasculitis)
•Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg

排除标准

•Visual acuity less than 1/10 on Snellen chart
•Antecedent of allergic reaction to any component of the therapeutic regimen

研究组 & 干预措施

1

Experimental

Rituximab

干预措施: Rituximab (Drug)

2

Active Comparator

Cytotoxics combination

干预措施: Cytotoxic Combination (Drug)

结局指标

主要结局

Visual acuity

时间窗: 6 months

次要结局

Inflammatory index for posterior uveitis(6 months)
Inflammatory index for retinal vasculitis, especially for edema(6 months)
Total Adjusted Disease Activity Index (TADAI)(6 months)

研究者

发起方

Tehran University of Medical Sciences

申办方类型

Other

研究点 (1)

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