Crohn's Disease Clinical Trial
Official title:
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
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.
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