Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tokyo Medical and Dental University
• Treatments: Adalimumab; Azathioprine; Infliximab

Criteria

Inclusion Criteria:

• Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150)

• Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)

Exclusion Criteria:

• Contraindication for infliximab, adalimumab, or azathioprine

• Lactating woman

• Presence of malignancy

• Within 3 month from intestinal surgery

• Presence of an end stoma

• Planned surgery