CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease (CREOLE)

June 21, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Value of Contrast-enhanced Ultrasonography and Magnetic Resonance Enterography to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease Complicated by Symptomatic Small Bowel Stricture

The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.

In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.

The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Ulb - Clinique Saint Luc
  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besancon, France, 25030
        • CHU Besançon
      • Bobigny, France, 93200
        • Hopital Avicennes
      • Clichy, France, 92110
        • Hopital Beaujon
      • Le Kremlin Bicetre, France, 94275
        • Hôpital Bicêtre
      • Lille, France, 59037
        • CHRU Lille
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75012
        • Hopital St Antoine
      • Paris, France, 75018
        • Hôpital Bichat
      • Reims, France, 51000
        • CHU Reims
      • Rouen, France, 76031
        • CHU Rouen
      • Tours, France, 37044
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives

Description

Inclusion Criteria:

  • Crohn's disease defined according to the usual endoscopic, histological, and radiological criteria
  • Small bowel (jejunum or ileum) stricture identified by radiography or endoscopy
  • Obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks
  • Failure of corticosteroids and/or immunosuppressives and indication for anti-TNF therapy

Exclusion Criteria:

  • Nonresolving complete bowel obstruction
  • Previous anti-TNF therapy

  • Contraindication to anti-TNF therapy:

    • Intra-abdominal, intra-mural or extramural abscess
    • Active infection
    • Severe infection during the previous 2 months
    • Nontreated latent tuberculosis
    • Heart failure
    • Active malignancy during the previous 5 years
    • Demyelinating neurological disease
  • Modification of the treatment of Crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide
  • Contraindication to MR enterography or contrast-enhanced ultrasonography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)
Time Frame: 6 months minus baseline
6 months minus baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the obstructive symptom scale at the various visits between D0 and W24
Time Frame: 6 months minus baseline
6 months minus baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Yoram BOUHNIK, MD,PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Principal Investigator: Franck CARBONNEL, MD,PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 21, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2008-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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