Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evaluation group

Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.

All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :

* Upper tract location : upper endoscopy
* Colorectal location : colonoscopy
* Perianal location : pelvic MRI
* All patients : abdominal MRI

Group Type EXPERIMENTAL

Abdominal MRI

Intervention Type PROCEDURE

Abdominal MRI to realize within 4 months following inclusion

Upper endoscopy

Intervention Type PROCEDURE

Upper endoscopy to realize within 4 months following inclusion

Colonoscopy

Intervention Type PROCEDURE

Colonoscopy to realize within 4 months following inclusion

Pelvic MRI

Intervention Type PROCEDURE

Pelvic MRI to realize within 4 months following inclusion

Interventions

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Abdominal MRI

Abdominal MRI to realize within 4 months following inclusion

Intervention Type PROCEDURE

Upper endoscopy

Upper endoscopy to realize within 4 months following inclusion

Intervention Type PROCEDURE

Colonoscopy

Colonoscopy to realize within 4 months following inclusion

Intervention Type PROCEDURE

Pelvic MRI

Pelvic MRI to realize within 4 months following inclusion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients over 18 years old
* Active or Inactive Crohn's Disease
* Previously enrolled in RAPID clinical trial

Exclusion Criteria

* Pregnant or nursing woman
* Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
* Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No