Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences (FISTULE)

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Anal Fistula
• Intervention / Treatment: Other: Pelvis Magnetic resonance imaging

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with perianal fistulizing Crohn's disease	Other: Pelvis Magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of severity of Crohn's disease with Van Assche MRI score	day 0
Evaluation of severity of Crohn's disease with Van Assche MRI score	6 months
Evaluation of severity of Crohn's disease with Van Assche MRI score	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of activity of Crohn's disease with CDAI score	day 0
Evaluation of activity of Crohn's disease with CDAI score	6 months
Evaluation of activity of Crohn's disease with CDAI score	1 year
Evaluation of severity of perianal injury with PDAI score	day 0
Evaluation of severity of perianal injury with PDAI score	6 months
Evaluation of severity of perianal injury with PDAI score	1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Laurent Peyrin-Biroulet, Pr, Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Inflammatory Bowel Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Crohn Disease; Rectal Fistula
• Other Study ID Numbers: 2010-A00588-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No