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

Study Overview
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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.

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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Procedure: Abdominal MRI
* Procedure: Upper endoscopy
* Procedure: Colonoscopy
* Procedure: Pelvic MRI


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation group<br>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 | Procedure: Abdominal MRI<br>* Abdominal MRI to realize within 4 months following inclusion<br>Procedure: Upper endoscopy<br>* Upper endoscopy to realize within 4 months following inclusion<br>Procedure: Colonoscopy<br>* Colonoscopy to realize within 4 months following inclusion<br>Procedure: Pelvic MRI<br>* Pelvic MRI to realize within 4 months following inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive damage | Evaluate digestive damage in Crohn's Disease by using Lemann Index | 5 to 10 years after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of the digestive damage evolution | Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index | 5 to 10 years after diagnosis | 
| Predictive factors of the digestive damage evolution | Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis. | 5 to 10 years after diagnosis | 
| Variation of Lemann Index | Variation of Lemann Index 5 to 10 years after diagnosis | 5 to 10 years after diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Digestive Damage, Lemann Index