NCT02687828已完成不适用
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients
AbbVie10 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2016年2月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 10
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be an adult >= 19 years
- •Subjects who are eligible to be treated with adalimumab for intestinal Behcet's disease in accordance with the approved label in Korea
- •Subjects provide written authorization form for use/disclose of personal health data prior to participating in this study
排除标准
- •Subjects who are contraindicated to any anti-TNF agent
- •Female subjects who are pregnant or breast feeding
- •Subjects who are participating in other interventional clinical trials
结局指标
主要结局
Number of participants with adverse events
时间窗: From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks
All adverse events including serious and unexpected events will be assessed.
次要结局
- Number of participants with adverse drug reactions(From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks)
研究者
研究点 (10)
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