Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
NCT ID: NCT02332356
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2014-09-30
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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step up
Procedure: MREC patients receive therapeutic step up
azathioprine or adalimumab and infliximab
observation step up
No interventions assigned to this group
step down
Procedure: MREC patients receive therapeutic step down
azathioprine or adalimumab and infliximab
observation step down
No interventions assigned to this group
Interventions
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azathioprine or adalimumab and infliximab
Eligibility Criteria
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Inclusion Criteria
* Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)
Exclusion Criteria
* Lactating woman
* Presence of malignancy
* Within 3 month from intestinal surgery
* Presence of an end stoma
* Planned surgery
16 Years
65 Years
ALL
No
Sponsors
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Tokyo Medical and Dental University
OTHER
Responsible Party
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Toshimitsu Fujii, MD PhD
Gastroenterology and Hepatology
Principal Investigators
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Toshimitsu Fujii
Role: PRINCIPAL_INVESTIGATOR
Tokyo Medical and Dental University Hospital
Locations
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Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
Tokyo, , Japan
Countries
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References
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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.
Other Identifiers
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MREC study
Identifier Type: -
Identifier Source: org_study_id