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Infliximab for non-Crohn Anal Fistulas
EU CTIS ID: 2022-502263-38-00
What this study is testing
To investigate the efficacy of adjuvant anti-TNFα treatment to standard surgical treatment of complex cryptoglandular anal fistulas.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 1. Pregnancy
- 2. Colostomy
- 3. Smoker or non-smoker for < 8 weeks
- 4. Anti-TNFα treatment contradicted (chronic infections or malignancy)
- 5. MRI-scan contradicted
- 6. Females of child-bearing age not using contraception
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.