NCT02258867终止3 期
A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Time to first ocular exacerbation
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
- •Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
- •Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline
- •Effective contraceptive measures
排除标准
- •Infectious uveitis and masquerade syndromes
- •End stage ocular disease
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •Active tuberculosis disease
- •History of recurrent infection or predisposition to infection; active ocular infection
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Gevokizumab
Experimental
干预措施: Gevokizumab (Drug)
结局指标
主要结局
Time to first ocular exacerbation
时间窗: Randomization through Day 280
Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.
次要结局
未报告次要终点
研究者
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