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

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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Key information

Conditions

Crohn's Disease Constriction, Pathologic Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulb - Clinique Saint Luc, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)

Time frame: 6 months minus baseline

Secondary outcomes

Change of the obstructive symptom scale at the various visits between D0 and W24

Time frame: 6 months minus baseline

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study 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

Acronym: CREOLE

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 17, 2010
Registry last updated: Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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