drugset / Trial / NCT02247258
Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.
Phase 2
Terminated
63 enrolled
Universitaire Ziekenhuizen KU Leuven
International organization for the study of inflammatory bowel disease (IOIBD) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 2 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 2.5 mg/kg | — |