- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332356
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 Contact
- Name: Toshimitsu Fujii
- Phone Number: +81 3 58035877
- Email: tfujii.gast@tmd.ac.jp
Study Locations
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-
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Tokyo, Japan, 113-8519
- Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
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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
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No Intervention: observation step up
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Active Comparator: step down
Procedure: MREC patients receive therapeutic step down
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No Intervention: observation step down
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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.
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
- Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13.
- Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25.
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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Tumor Necrosis Factor Inhibitors
- Adalimumab
- Infliximab
- Azathioprine
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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