NCT02247258

Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.

Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate if in the prevention of postoperative recurrence of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.

Conditions

• Crohn Disease
• Recurrence
• Azathioprine
• Prevention

Interventions

Type	Name	Description
DRUG	Azathioprine	See arm/group descriptions
DRUG	Azathioprine in case of endoscopic recurrence	See arm/group descriptions
PROCEDURE	Ileocolonoscopy	See arm/group descriptions
PROCEDURE	Small bowel follow trough	See arm/group descriptions

Timeline

• Start date: 2005-10-01
• Primary completion: 2014-04-01
• Completion: 2015-05-01
• First posted: 2014-09-23
• Last updated: 2015-05-29

Locations

4 sites across 3 countries: Belgium, Czechia, Greece