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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02332356
Date of registration: 04/01/2015
Prospective Registration: No
Primary sponsor: Tokyo Medical and Dental University
Public title: Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Scientific title: Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Date of first enrolment: September 2014
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02332356
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Toshimitsu Fujii
Address: 
Telephone: +81 3 58035877
Email: tfujii.gast@tmd.ac.jp
Affiliation: 
Name:     Toshimitsu Fujii
Address: 
Telephone: +81 3 58035877
Email: tfujii.gast@tmd.ac.jp
Affiliation: 
Name:     Toshimitsu Fujii
Address: 
Telephone:
Email:
Affiliation:  Tokyo Medical and Dental University Hospital
Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: azathioprine or adalimumab and infliximab
Primary Outcome(s)
The rate of clinical remission at 104 weeks. [Time Frame: 104 weeks]
Secondary Outcome(s)
The rate of hospitalization and operation [Time Frame: 104 weeks]
Secondary ID(s)
MREC study
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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