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Register:	ClinicalTrials.gov
Last refreshed on:	1 February 2021
Main ID:	NCT02856763
Date of registration:	21/06/2015
Prospective Registration:	No
Primary sponsor:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Public title:	Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess MICA
Scientific title:	Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
Date of first enrolment:	April 2013
Target sample size:	125
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02856763
Study type:	Observational
Study design:
Phase:

Countries of recruitment
France

Contacts

Name:	Guillaume Pineton de Chambrun, MD
Address:
Telephone:
Email:
Affiliation:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Name:	Yoram Bouhnik, MD
Address:
Telephone:
Email:
Affiliation:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age greater than 18 years.

- Diagnosis of Crohn's disease (confirmed by clinical evaluation and a combination of
endoscopic, histological, radiological, and/or biochemical investigations according to
European guidelines)

- AND diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to
radiologic criteria confirmed by US, CT or magnetic resonance enterography (MRE).

- In patients who have not responded despite a full and adequate course of therapy with
a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical
contraindications for such therapies

- Written consent MAIN

Exclusion Criteria:

- Age under 18 years. - Absence of written consent. - Post-operative abscess (occurring
within 12 weeks after intestinal resection). - Isolated intra-parietal abscess of
small intestine or colon. - Need for immediate surgery including irreversible bowel
obstruction, peritonitis or uncontrolled sepsis. - Perineal abscess complicating
perianal Crohn's disease. - Abscess developing under anti-TNF therapy. - Previous
failure or intolerance to adalimumab. - Contraindication to anti-TNF therapy.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intervention(s)

Primary Outcome(s)

Identification of predictive factors of adalimumab (anti TNF) failure at Week 24. [Time Frame: Week 24]

Secondary Outcome(s)

Death [Time Frame: Week 24]

hospital stay [Time Frame: Week 48]

Clinical Remission [Time Frame: Week 48]

Evolution of items measured by MRE [Time Frame: Week 24]

SAE [Time Frame: Week 48]

Monitoring of obstructive symptoms [Time Frame: Week 48]

Secondary ID(s)

2012-000982-19

GETAID 2012-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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