JPRN-jRCTs021200013已完成3 期
A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST
Moroi Rintao0 个研究点目标入组 80 人开始时间: 2020年7月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Japanese Crohn's disease
- •From moderate to severe activity
- •(CDAI > 220)
- •Performance Status:0-2
- •Outpatient (Around 1 week admission is permitted).
排除标准
- •With stoma.
- •With surgical lesion such as stenosis or abscess.
- •Inpatient with intravenous hyperalimentation.
- •History of allergy for Ustekinumab or Budesonide.
- •Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum, or gives the breast to a child.
- •With psychiatric disorder
- •Within 5 years after diagnosis or treatment of malignant tumor.
- •Patient who has active infection.
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