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

NCT02247258 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-05-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • International organization for the study of inflammatory bowel disease (IOIBD)

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Gert Van Assche, MD PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2014-04-30
Completion
2015-05-31

Countries

  • Belgium
  • Czechia
  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247258 on ClinicalTrials.gov