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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• 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: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/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
• 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