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

Crohn's Disease Clinical Trial

— DESTIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549976
• Other study ID #: 2015-4
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 2018

Study information

• Verified date: July 2018
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Procedure:
• Abdominal MRI
Abdominal MRI to realize within 4 months following inclusion
• Upper endoscopy
Upper endoscopy to realize within 4 months following inclusion
• Colonoscopy
Colonoscopy to realize within 4 months following inclusion
• Pelvic MRI
Pelvic MRI to realize within 4 months following inclusion

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

References & Publications (2)

Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30. — View Citation

Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panés J, Schölmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lémann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digestive damage	Evaluate digestive damage in Crohn's Disease by using Lemann Index	5 to 10 years after diagnosis
Secondary	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
Secondary	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
Secondary	Variation of Lemann Index	Variation of Lemann Index 5 to 10 years after diagnosis	5 to 10 years after diagnosis

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