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

NCT ID: NCT01183403

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoram BOUHNIK, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Franck CARBONNEL, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Locations

Ulb - Clinique Saint Luc

Brussels, , Belgium

Chu Amiens

Amiens, , France

Chu Besancon

Besançon, , France

Hopital Avicennes

Bobigny, , France

Hopital Beaujon

Clichy, , France

Hopital Bicetre

Le Kremlin-Bicêtre, , France

Chru Lille

Lille, , France

Chu Montpellier

Montpellier, , France

Chu Nantes

Nantes, , France

CHU NICE

Nice, , France

Hopital Lariboisiere

Paris, , France

Hopital Saint Louis

Paris, , France

Hopital St Antoine

Paris, , France

Hopital Cochin

Paris, , France

Hopital Bichat

Paris, , France

Chu Reims

Reims, , France

Chu Rouen

Rouen, , France

Chu Tours

Tours, , France

Countries

Belgium; France

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Related Links

http://www.getaid.org

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Other Identifiers

GETAID 2008-3

Identifier Type: -

Identifier Source: org_study_id