Infliximab for non-Crohn Anal Fistulas
- Conditions
- Anal fistulaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-502263-38-00
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
1.Complex (i.e. intershincteric or low transsphincteric fistulas with extension, high transsphincteric- ,supra- or ekstrasphincteric fistulas cryptoglandular fistulas that persist in spite of 6 months seton drainage and repeated curettage every 8- 12 weeks and where the presence of extensions and/or inflammatory activity contradicts surgical closure of the fistula, 2.Not diagnosed with Crohn´s disease implying a.Normal ileocolonoscopy < 6 months b.Normal capsule endoscopy of the small bowel < 6 months c.No granulomas in tissue samples from external fistula opening, 3.Age 18-65 years, 4.Speaks and understands Danish, 5. Received surgical standard treatment (repeated curettage and seton) for at least 6 months
1.Pregnancy, 2.Colostomy, 3.Smoker or non-smoker for < 8 weeks, 4.Anti-TNFa treatment contradicted (chronic infections or malignancy), 5. MRI-scan contradicted, 6. Females of child-bearing age not using contraception
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