MedTrace Logo

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

NCT02332356 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

DRUG

azathioprine or adalimumab and infliximab

Sponsors & Collaborators

  • Tokyo Medical and Dental University

    lead OTHER

Principal Investigators

  • Toshimitsu Fujii · Tokyo Medical and Dental University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Japan

Study Locations

More Related Trials

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 NCT02332356 on ClinicalTrials.gov