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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status: Completed

Conditions: Crohn's Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01183403

GETAID 2008-3

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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