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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01183403
First received: September 11, 2009
Last updated: April 16, 2012
Last verified: April 2012
History of Changes

September 11, 2009
April 16, 2012
January 2010
July 2012   (final data collection date for primary outcome measure)
% 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 ]
% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01183403 on ClinicalTrials.gov Archive Site
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 ]
Change of the obstructive symptom scale at the various visits between D0 and W24 [ Time Frame: at WEEK 24 ] [ Designated as safety issue: No ]
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CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives
Crohn's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT01183403
GETAID 2008-3
No
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Not Provided
Principal Investigator: Yoram BOUHNIK, MD,PhD GETAID
Principal Investigator: Franck CARBONNEL, MD,PhD GETAID
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP