CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease (CREOLE)
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Purpose
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.
| Condition |
|---|
|
Crohn's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) [ Time Frame: 6 months minus baseline ] [ Designated as safety issue: No ]
- Change of the obstructive symptom scale at the various visits between D0 and W24 [ Time Frame: 6 months minus baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives
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
Contacts and Locations| Belgium | |
| Ulb - Clinique Saint Luc | |
| Bruxelles, Belgium, 1200 | |
| France | |
| Chu Amiens | |
| Amiens, France, 80054 | |
| Chu Besancon | |
| Besancon, France, 25030 | |
| Hopital Avicennes | |
| Bobigny, France, 93200 | |
| Hopital Beaujon | |
| Clichy, France, 92110 | |
| Hopital Bicetre | |
| Le Kremlin Bicetre, France, 94275 | |
| Chru Lille | |
| Lille, France, 59037 | |
| Chu Montpellier | |
| Montpellier, France, 34295 | |
| Chu Nantes | |
| Nantes, France, 44093 | |
| CHU NICE | |
| Nice, France, 06202 | |
| Hopital Bichat | |
| Paris, France, 75018 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Hopital Saint Louis | |
| Paris, France, 75010 | |
| Hopital St Antoine | |
| Paris, France, 75012 | |
| Hopital Lariboisiere | |
| Paris, France, 75010 | |
| Chu Reims | |
| Reims, France, 51000 | |
| Chu Rouen | |
| Rouen, France, 76031 | |
| Chu Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Yoram BOUHNIK, MD,PhD | GETAID |
| Principal Investigator: | Franck CARBONNEL, MD,PhD | GETAID |
More Information
Additional Information:
Publications:
| Responsible Party: | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| ClinicalTrials.gov Identifier: | NCT01183403 History of Changes |
| Other Study ID Numbers: | GETAID 2008-3 |
| Study First Received: | September 11, 2009 |
| Last Updated: | April 16, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
|
stricture anti-TNF ileal Crohn'Disease |
patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013