drugset / Trial / NCT02247258

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

NCT02247258

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2005-10
Primary completion
2014-04
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 2 mg/kg
Comparator Azathioprine Small molecule 2.5 mg/kg

Indications