Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 4, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedNovember 27, 2023
November 1, 2023
9.5 years
January 4, 2015
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of clinical remission at 104 weeks.
104 weeks
Secondary Outcomes (1)
The rate of hospitalization and operation
104 weeks
Study Arms (4)
step up
ACTIVE COMPARATORProcedure: MREC patients receive therapeutic step up
observation step up
NO INTERVENTIONstep down
ACTIVE COMPARATORProcedure: MREC patients receive therapeutic step down
observation step down
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Contraindication for infliximab, adalimumab, or azathioprine
- Lactating woman
- Presence of malignancy
- Within 3 month from intestinal surgery
- Presence of an end stoma
- Planned surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
Tokyo, 113-8519, Japan
Related Publications (2)
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.
PMID: 24732015BACKGROUNDHyun 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.
PMID: 21484957BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toshimitsu Fujii
Tokyo Medical and Dental University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterology and Hepatology
Study Record Dates
First Submitted
January 4, 2015
First Posted
January 6, 2015
Study Start
September 1, 2014
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
November 27, 2023
Record last verified: 2023-11