NCT02375685终止3 期
A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 25
- 主要终点
- Safety endpoints (adverse events, ...)
研究概览
简要总结
The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
- •Male or female, age ≥18 (or legal age of majority in the country) at selection.
- •For subject with reproductive potential, a willingness to use highly effective contraceptive measures
排除标准
- •Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
- •Infectious uveitis and masquerade syndrome
- •History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
- •Currently active infectious disease.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety endpoints (adverse events, ...)
时间窗: 108 weeks
次要结局
未报告次要终点
研究者
研究点 (25)
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ong-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumabchronic non-infectious uveitisMedDRA version: 17.0Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: PTClassification code 10069034Term: Tubulointerstitial nephritis and uveitis syndromeSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 17.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862MedDRA version: 17.0Level: LLTClassification code 10071139Term: Behcet's uveitisSystem Organ Class: 100000004866MedDRA version: 17.0Level: LLTClassification code 10042745Term: Sympathetic uveitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: PTClassification code 10012692Term: Diabetic uveitisSystem Organ Class: 10015919 - Eye disordersMedDRA version: 17.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersEUCTR2013-004973-29-GRInstitut de Recherches Internationales Servier300
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