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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332356

Enrollment

100

Registered

2015-01-06

Start date

2014-09-30

Completion date

2024-03-31

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes

Brief 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.

Interventions

DRUGazathioprine or adalimumab and infliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
The rate of clinical remission at 104 weeks.	104 weeks

Secondary

Measure	Time frame
The rate of hospitalization and operation	104 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026