EUCTR2012-004098-26-FR
进行中（未招募）
1 期
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Crohn's Disease
- 发起方
- AstraZeneca AB
- 入组人数
- 121
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Diagnosed ileal, ileo\-colonic, or colonic CD at least 6 months prior to screening.
- •Men or women age 18 \- 65 years at the time of screening.
- •Moderate\-severe active CD, defined by a CDAI score of \= 220 and \= 450 at Day 1\.
- •No known history of active TB.
- •Received at least one anti\-TNFa agent for the treatment of CD and did not initially respond.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 120
- •F.1\.3 Elderly (\>\=65 years) no
排除标准
- •Pregnant or breastfeeding women.
- •Presence of ileostomy and/or colostomy.
- •Short bowel syndrome.
- •Bowel performation or obstruction.
- •History of cancer.
结局指标
主要结局
未指定
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