Crohn's Disease Clinical Trial
— CREOLEOfficial 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
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ulb - Clinique Saint Luc | Bruxelles | |
| France | Chu Amiens | Amiens | |
| France | Chu Besancon | Besancon | |
| France | Hopital Avicennes | Bobigny | |
| France | Hopital Beaujon | Clichy | |
| France | Hopital Bicetre | Le Kremlin Bicetre | |
| France | Chru Lille | Lille | |
| France | Chu Montpellier | Montpellier | |
| France | Chu Nantes | Nantes | |
| France | CHU NICE | Nice | |
| France | Hopital Bichat | Paris | |
| France | Hopital Cochin | Paris | |
| France | Hopital Lariboisiere | Paris | |
| France | Hopital Saint Louis | Paris | |
| France | Hopital St Antoine | Paris | |
| France | Chu Reims | Reims | |
| France | Chu Rouen | Rouen | |
| France | Chu Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
Belgium, France,
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Louis E, Boverie J, Dewit O, Baert F, De Vos M, D'Haens G; Belgian IBD Research Group. Treatment of small bowel subocclusive Crohn's disease with infliximab: an open pilot study. Acta Gastroenterol Belg. 2007 Jan-Mar;70(1):15-9. — View Citation
Masselli G, Brizi GM, Parrella A, Minordi LM, Vecchioli A, Marano P. Crohn disease: magnetic resonance enteroclysis. Abdom Imaging. 2004 May-Jun;29(3):326-34. — View Citation
Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. Epub 2007 Sep 25. — View Citation
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* Note: There are 26 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) | 6 months minus baseline | No | |
| Secondary | Change of the obstructive symptom scale at the various visits between D0 and W24 | 6 months minus baseline | No |
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