NCT00724529已完成不适用
Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 938
- 主要终点
- To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice
研究概览
简要总结
The purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. This is a post-marketing surveillance study.
详细描述
The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe active Crohn's disease: the patients with severe active Crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments.
- •Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
- •Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice
时间窗: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.
次要结局
- To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice(The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis.)
研究者
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