Status:
COMPLETED
CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01183403
Start Date
January 1 2010
End Date
July 1 2012
Last Update
June 23 2015
Active Locations (18)
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1
Ulb - Clinique Saint Luc
Brussels, Belgium, 1200
2
Chu Amiens
Amiens, France, 80054
3
Chu Besancon
Besançon, France, 25030
4
Hopital Avicennes
Bobigny, France, 93200