Clinical trial

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

Name

MREC study

Description

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.

Trial arms

Trial start

2014-09-01

Estimated PCD

2024-03-01

Trial end

2024-03-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

azathioprine or adalimumab and infliximab

Arms:

step down, step up

Size

100

Primary endpoint

The rate of clinical remission at 104 weeks.

104 weeks

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2023-11-27

1 organization

1 product

1 indication

Organization

Tokyo Medical and Dental University

Product

Azathioprine

Indication

Crohn's Disease