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.
- Conditions
- Crohn's disease
- Registration Number
- EUCTR2006-004784-58-FR
- Lead Sponsor
- CHRU de Lille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
- 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
- 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,
- ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method