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

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ClinicalTrials.gov Identifier: NCT02883296
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Anal Fistula Crohn's Disease Other: Pelvis Magnetic resonance imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences
Study Start Date : April 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Evaluation of severity of Crohn's disease with Van Assche MRI score [ Time Frame: day 0 ]
  2. Evaluation of severity of Crohn's disease with Van Assche MRI score [ Time Frame: 6 months ]
  3. Evaluation of severity of Crohn's disease with Van Assche MRI score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluation of activity of Crohn's disease with CDAI score [ Time Frame: day 0 ]
  2. Evaluation of activity of Crohn's disease with CDAI score [ Time Frame: 6 months ]
  3. Evaluation of activity of Crohn's disease with CDAI score [ Time Frame: 1 year ]
  4. Evaluation of severity of perianal injury with PDAI score [ Time Frame: day 0 ]
  5. Evaluation of severity of perianal injury with PDAI score [ Time Frame: 6 months ]
  6. Evaluation of severity of perianal injury with PDAI score [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883296


Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Laurent Peyrin-Biroulet, Pr Service d'Hépato Gastro-entérologie Hôpital BRABOIS- CHU de NANCY
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02883296    
Other Study ID Numbers: 2010-A00588-31
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases