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The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis. Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months. Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chu Clermont-Ferrand
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
CHRU Lille
Lille, France
CHU NICE
Nice, France
Hopital Saint Louis
Paris, France
Hopital Saint-Antoine
Paris, France
IMM
Paris, France
CHU Bordeaux - Pessac
Pessac, France
Chu Toulouse
Toulouse, France
Start Date
December 1, 2015
Primary Completion Date
February 1, 2018
Completion Date
February 1, 2018
Last Updated
July 31, 2018
54
ACTUAL participants
Abdominal MRI
PROCEDURE
Upper endoscopy
PROCEDURE
Colonoscopy
PROCEDURE
Pelvic MRI
PROCEDURE
Lead Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808