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

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT01183403
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-11
• Study Start: 2010-01
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of the obstructive symptom scale at the various visits between D0 and W24	6 months minus baseline

Trial Locations

Locations (18)

Ulb - Clinique Saint Luc; 🇧🇪 Bruxelles, Belgium

Chu Amiens; 🇫🇷 Amiens, France

Chu Besancon; 🇫🇷 Besancon, France

Hopital Beaujon; 🇫🇷 Clichy, France

Chu Tours; 🇫🇷 Tours, France

Chu Reims; 🇫🇷 Reims, France

Hopital Avicennes; 🇫🇷 Bobigny, France

Hopital Bicetre; 🇫🇷 Le Kremlin Bicetre, France

Chru Lille; 🇫🇷 Lille, France

Chu Montpellier; 🇫🇷 Montpellier, France

Chu Nantes; 🇫🇷 Nantes, France

CHU NICE; 🇫🇷 Nice, France

Chu Rouen; 🇫🇷 Rouen, France

Hopital Lariboisiere; 🇫🇷 Paris, France

Hopital Saint Louis; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital St Antoine; 🇫🇷 Paris, France

Hopital Bichat; 🇫🇷 Paris, France