Clinical trial NCT02883296: Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
Official title: Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Crohn's Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of severity of Crohn's disease with Van Assche MRI score
timeFrame: day 0
measure: Evaluation of severity of Crohn's disease with Van Assche MRI score
timeFrame: 6 months
measure: Evaluation of severity of Crohn's disease with Van Assche MRI score
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of activity of Crohn's disease with CDAI score
timeFrame: day 0
measure: Evaluation of activity of Crohn's disease with CDAI score
timeFrame: 6 months
measure: Evaluation of activity of Crohn's disease with CDAI score
timeFrame: 1 year
measure: Evaluation of severity of perianal injury with PDAI score
timeFrame: day 0
measure: Evaluation of severity of perianal injury with PDAI score
timeFrame: 6 months
measure: Evaluation of severity of perianal injury with PDAI score
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY
name: Laurent Peyrin-Biroulet, Pr
role: PRINCIPAL_INVESTIGATOR
References: