NCT06739278尚未招募不适用
Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab
Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2024年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- imaging remission rate of anal fistula
研究概览
简要总结
This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.
详细描述
Participants in the study receive ustekinumab injections as part of routine medical care. The study just observes the efficacy retrospectively and does not interfere with treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Perianal Fistulizing Crohn's Disease
- •Receive ustekinumab therapy
排除标准
- •Ustekinumab combined with hormones, immunosuppressants, other biologics or small molecule drugs
- •Combined with other autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Graves disease, etc.
- •Combined with serious infectious diseases, such as active tuberculosis, EBV infection, cytomegalovirus infection, etc.
- •Combined with malignant tumor
- •Clinical data missing ≥30% or no follow-up
结局指标
主要结局
imaging remission rate of anal fistula
时间窗: Treatment week 0 to 32
次要结局
未报告次要终点
研究者
研究点 (1)
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