NCT Number: NCT02883296
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
Main purposes of this study are :
* Analysis of relapse risk of anal fistulae with prospective follow-up of patients undergoing pelvic MRI every 6 months for one year. This monitoring also determines if the presence of path of fistulae visible on MRI during inclusion visit is associated to increased risk of perianal abscess under infliximab or adalimumab treatment. * Evaluation of interest of new magnetic resonance imaging sequences for detection of persistent anal fistulae under infliximab or adalimumab treatment.
Secondary purposes are:
* Description of patients with one or more paths of fistulae visible with MRI after at least one year of treatment with infliximab or adalimumab administered for anal fistulae and showing a complete healing of fistulae at clinical examination of inclusion visit. * Identification of predictive factors (included the presence of paths of fistulae visible with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up after inclusion visit.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Aware and cooperative, giving written consent
- Crohn's disease diagnosed with clinical, biological, endoscopic and/or radiologic criteria
- Patient treated with infliximab or adalimumab for perianal fistulizing Crohn's disease since at least one year
- Absence of drainage seton at inclusion
- Absence of active perianal lesions at inclusion: absence of suggestive symptoms and normal proctologic clinical examination without general anesthesia
- Patient with MRI monitoring for perianal fistulizing Crohn's disease
Exclusion criteria
- Patient under juridical protection or without affiliation to social security
- Refusal or impossibility of giving informed consent
- Patient not followed-up by MRI or having a contraindication for MRI, especially the presence of cardiac stimulators or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or encephalic metallic foreign bodies, endo-prostheses placed since at least 4 weeks or osteosynthesis material placed since less than 6 weeks or gadolinium intolerance history
- Surgery for Crohn's disease already planned at inclusion visit, individual participating to another study evaluating efficacy and/or tolerance of medical or surgical treatment for perianal fistulae of Crohn's disease
- Patient treated with anti-TNF for luminal Crohn's disease
- Patient having active perineal lesions
Treatment and study plan
Primary outcomes
-
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: day 0
-
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: 6 months
-
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time frame: 1 year
Secondary outcomes
-
Evaluation of activity of Crohn's disease with CDAI score
Time frame: day 0
-
Evaluation of activity of Crohn's disease with CDAI score
Time frame: 6 months
-
Evaluation of activity of Crohn's disease with CDAI score
Time frame: 1 year
-
Evaluation of severity of perianal injury with PDAI score
Time frame: day 0
-
Evaluation of severity of perianal injury with PDAI score
Time frame: 6 months
-
Evaluation of severity of perianal injury with PDAI score
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
Central Hospital, Nancy, France
Other
Registry information
Acronym: FISTULE
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Aug 30, 2016
- Registry last updated
- Apr 28, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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