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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Completed; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Azathioprine OR Mesalazine

Study type: Interventional

Funder types: Other

Identifiers

NCT00976690

GETAID 2001-1

Details and patient eligibility

About

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

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

1

Active Comparator group

Description:

Azathioprine : 2mg/kg/day

Treatment:

Drug: Azathioprine OR Mesalazine

2

Active Comparator group

Description:

Mesalazine : 4g/day

Treatment:

Drug: Azathioprine OR Mesalazine