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

Tokyo Medical and Dental University

Status and phase: Active, not recruiting; Phase 3

Conditions: Crohn Disease

Treatments: Drug: azathioprine or adalimumab and infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02332356

MREC study

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

step up

Active Comparator group

Description:

Procedure: MREC patients receive therapeutic step up

Treatment:

Drug: azathioprine or adalimumab and infliximab

observation step up

No Intervention group

step down

Active Comparator group

Description:

Procedure: MREC patients receive therapeutic step down

Treatment:

Drug: azathioprine or adalimumab and infliximab

observation step down

No Intervention group