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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01183403
First received: September 11, 2009
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) [ Time Frame: 6 months minus baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of the obstructive symptom scale at the various visits between D0 and W24 [ Time Frame: 6 months minus baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183403

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

Additional Information:
Publications:

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT01183403     History of Changes
Other Study ID Numbers: GETAID 2008-3
Study First Received: September 11, 2009
Last Updated: April 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
stricture
anti-TNF
ileal Crohn'Disease
patients with ileal Crohn's disease complicated by
symptomatic stricture after failure of corticosteroids
and/or immunosuppressives

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014