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NCT02332356 Clinical Trial

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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02332356
Other study ID # MREC study
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 2014
Est. completion date March 2024

Study information
Verified date November 2023
Source Tokyo Medical and Dental University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• azathioprine or adalimumab and infliximab

Locations
Country Name City State
Japan Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of clinical remission at 104 weeks. 104 weeks
Secondary The rate of hospitalization and operation 104 weeks
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