Clinical trial NCT01183403: CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: stricture
anti-TNF
ileal Crohn'Disease
patients with ileal Crohn's disease complicated by
symptomatic stricture after failure of corticosteroids
and/or immunosuppressives
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives

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.


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

Primary outcomes:
measure: % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)
timeFrame: 6 months minus baseline
Secondary outcomes:
measure: Change of the obstructive symptom scale at the various visits between D0 and W24
timeFrame: 6 months minus baseline
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Ulb - Clinique Saint Luc
city: Amiens
country: France
facility: Chu Amiens
city: Besancon
country: France
facility: Chu Besancon
city: Bobigny
country: France
facility: Hopital Avicennes
city: Clichy
country: France
facility: Hopital Beaujon
city: Le Kremlin Bicetre
country: France
facility: Hopital Bicetre
city: Lille
country: France
facility: Chru Lille
city: Montpellier
country: France
facility: Chu Montpellier
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Bichat
city: Reims
country: France
facility: Chu Reims
city: Rouen
country: France
facility: Chu Rouen
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Yoram BOUHNIK, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Franck CARBONNEL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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