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

NCT01183403 | Completed

• 1 other identifier: GETAID 2008-3
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 18

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.

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

Outcome Measures

Primary Outcomes (1)

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

  6 months minus baseline

Secondary Outcomes (1)

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

  6 months minus baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead

Study Sites (18)

Ulb - Clinique Saint Luc

Brussels, 1200, Belgium

Location

Chu Amiens

Amiens, 80054, France

Location

Chu Besancon

Besançon, 25030, France

Location

Hopital Avicennes

Bobigny, 93200, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Chru Lille

Lille, 59037, France

Location

Chu Montpellier

Montpellier, 34295, France

Location

Chu Nantes

Nantes, 44093, France

Location

CHU NICE

Nice, 06202, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital St Antoine

Paris, 75012, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Bichat

Paris, 75018, France

Location

Chu Reims

Reims, 51000, France

Location

Chu Rouen

Rouen, 76031, France

Location

Chu Tours

Tours, 37044, France

Location

Related Publications (27)

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  PMID: 12541166 BACKGROUND

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  PMID: 15354341 BACKGROUND

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  PMID: 17899102 BACKGROUND

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  PMID: 18925449 BACKGROUND

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Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoram BOUHNIK, MD,PhD

  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  PRINCIPAL INVESTIGATOR

• Franck CARBONNEL, MD,PhD

  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: August 17, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

BE (1); FR (17)