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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01183403

Acronym

CREOLE

Enrollment

Registered

2010-08-17

Start date

2010-01-31

Completion date

2012-07-31

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)	6 months minus baseline

Secondary

Measure	Time frame
Change of the obstructive symptom scale at the various visits between D0 and W24	6 months minus baseline

Countries

Belgium, France

Outcome results