NCT05645055招募中不适用
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clinical remission rate at 1 year
研究概览
简要总结
Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with stricturing Crohn's diseases
- •no surgical indication
- •patients with asymptomatic penetrating diseases
- •written consent acquired
排除标准
- •patients with surgical indication
- •patients with symptomatic penetrating diseases
- •contraindication of biologics
- •anticipating other trial
结局指标
主要结局
clinical remission rate at 1 year
时间窗: clinical remission rate at 1 year
clinical remission rate at 1 year (CDAI less than 150)
次要结局
- quality of life of patients assessed by Short form 12(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- surgical recurrence rate at 1 and 5 year(at 1 and 5 year)
- quality of life of patients assessed by IBDQ(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- score of obstructive(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- endoscopic recurrence rate at 1 and 5 year(at 1 and 5 year)
- clinical remission rate at 5 year(clinical remission rate at 5 year)
研究者
Zhu Weiming
Senior Doctor, Principal Investigator, Clinical Professor
Jinling Hospital, China
研究点 (1)
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