NCT02883296

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

April 28, 2021

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

August 23, 2016

Last Update Submit

April 27, 2021

Conditions

Anal FistulaCrohn's Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Patients with perianal fistulizing Crohn's disease

EXPERIMENTAL
Other: Pelvis Magnetic resonance imaging

Interventions

Pelvis Magnetic resonance imagingOTHER
Patients with perianal fistulizing Crohn's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patient with MRI monitoring for perianal fistulizing Crohn's disease

You may not qualify if:

  • 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
  • Patient treated with anti-TNF for luminal Crohn's disease
  • Patient having active perineal lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal FistulaCrohn Disease

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesGastroenteritis

Study Officials

  • Laurent Peyrin-Biroulet, Pr

    Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 30, 2016

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 28, 2021

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share