Back to resultsLong-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences (FISTULE)
Primary Purpose
Anal Fistula, Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvis Magnetic resonance imaging
Sponsored by
About this trial
This is an interventional prevention trial for Anal Fistula
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with perianal fistulizing Crohn's disease
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of severity of Crohn's disease with Van Assche MRI score
Evaluation of severity of Crohn's disease with Van Assche MRI score
Evaluation of severity of Crohn's disease with Van Assche MRI score
Secondary Outcome Measures
Evaluation of activity of Crohn's disease with CDAI score
Evaluation of activity of Crohn's disease with CDAI score
Evaluation of activity of Crohn's disease with CDAI score
Evaluation of severity of perianal injury with PDAI score
Evaluation of severity of perianal injury with PDAI score
Evaluation of severity of perianal injury with PDAI score
Full Information
NCT ID
NCT02883296
First Posted
August 23, 2016
Last Updated
April 27, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02883296
Brief Title
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
Acronym
FISTULE
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula, Crohn's Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with perianal fistulizing Crohn's disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pelvis Magnetic resonance imaging
Primary Outcome Measure Information:
Title
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time Frame
day 0
Title
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time Frame
6 months
Title
Evaluation of severity of Crohn's disease with Van Assche MRI score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of activity of Crohn's disease with CDAI score
Time Frame
day 0
Title
Evaluation of activity of Crohn's disease with CDAI score
Time Frame
6 months
Title
Evaluation of activity of Crohn's disease with CDAI score
Time Frame
1 year
Title
Evaluation of severity of perianal injury with PDAI score
Time Frame
day 0
Title
Evaluation of severity of perianal injury with PDAI score
Time Frame
6 months
Title
Evaluation of severity of perianal injury with PDAI score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Peyrin-Biroulet, Pr
Organizational Affiliation
Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
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