Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives83 enrolled

Overview

To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease

Interventions

Azathioprine OR MesalazineDRUG

Azathioprine : 2mg/kg/day Mesalazine : 4g/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * more than 18 years old * Clinical remission at inclusion time (CDAI\<150) * Having ileocolonic or colon resection 21 days before inclusion * Resection \> 50cm or subtotal colectomy with ileorectal anastomosis Exclusion Criteria: * Intolerance to one of both study treatment * Liver failure (TP\<60%) * Renal Failure (Creatinine \< Lab results)

Locations (14)

Chu Amiens

Amiens, France

Chu Besancon

Besançon, France

CHU CAEN

Caen, France

Hopital Beaujon

Outcomes

Primary Outcomes

Clinically and endoscopically recurrence at 12 and 24 months

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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