EUCTR2006-004784-58-FR进行中（未招募）1 期
An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.
CHRU de Lille0 个研究点目标入组 25 人开始时间: 2008年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men and women = 18 and = 65 years of age,
- •- Are capable of understanding and signing an informed consent
- •- Are considered eligible according to the following tuberculosis (TB) screening criteria,
- •- The presence of active disease (CDAI > 220, CRP > 10 mg/L),
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Have a medical contraindication for MRI enteroclysis,
- •- Use more than 15 mg of oral steroids (prednisone or equivalent) within the 2 weeks prior to baseline MRI. IV use of steroids is not allowed within that same period,
- •- Have a severe prestenotic dilation of the ileum on screening MRI (severe dilation is defined as > 2 times the luminal diameter of the unaffected ileum),
- •- Have had bowel resection of > 100 cm,
- •- Person with no social insurance,
- •- Have presence of an abdominal abscess,
- •- Have MRI enteroclysis confirmed internal fistula,
- •- Be considered ineligible according to the tuberculosis criteria,
- •- Have non conform screening laboratory tests results,
- •- Active participation in another clinical trial or having been included in a clinical trial until 3 months before screening,
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