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

November 21, 2023 updated by: Toshimitsu Fujii, MD PhD, Tokyo Medical and Dental University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 113-8519
        • Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: step up
Procedure: MREC patients receive therapeutic step up
Drug: azathioprine or adalimumab and infliximab
No Intervention: observation step up
Active Comparator: step down
Procedure: MREC patients receive therapeutic step down
Drug: azathioprine or adalimumab and infliximab
No Intervention: observation step down

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of clinical remission at 104 weeks.
Time Frame: 104 weeks
104 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of hospitalization and operation
Time Frame: 104 weeks
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Medical and Dental University

Investigators

  • Principal Investigator: Toshimitsu Fujii, Tokyo Medical and Dental University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 4, 2015

First Submitted That Met QC Criteria

January 4, 2015

First Posted (Estimated)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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