Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of clinical remission at 104 weeks.
研究概览
简要总结
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150)
- •Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)
排除标准
- •Contraindication for infliximab, adalimumab, or azathioprine
- •Lactating woman
- •Presence of malignancy
- •Within 3 month from intestinal surgery
- •Presence of an end stoma
- •Planned surgery
研究组 & 干预措施
step up
Procedure: MREC patients receive therapeutic step up
干预措施: azathioprine or adalimumab and infliximab (Drug)
step down
Procedure: MREC patients receive therapeutic step down
干预措施: azathioprine or adalimumab and infliximab (Drug)
结局指标
主要结局
The rate of clinical remission at 104 weeks.
时间窗: 104 weeks
次要结局
- The rate of hospitalization and operation(104 weeks)
研究者
Toshimitsu Fujii, MD PhD
Gastroenterology and Hepatology
Tokyo Medical and Dental University