Back to resultsTherapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Primary Purpose
Crohn Disease
Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
azathioprine or adalimumab and infliximab
Sponsored by
About this trial
This is an interventional prevention trial for Crohn Disease focused on measuring Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
Eligibility 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
Sites / Locations
- Gastroenterology and Hepatology, Tokyo Medical and Dental UNIVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
No Intervention
Active Comparator
No Intervention
Arm Label
step up
observation step up
step down
observation step down
Arm Description
Procedure: MREC patients receive therapeutic step up
Procedure: MREC patients receive therapeutic step down
Outcomes
Primary Outcome Measures
The rate of clinical remission at 104 weeks.
Secondary Outcome Measures
The rate of hospitalization and operation
Full Information
NCT ID
NCT02332356
First Posted
January 4, 2015
Last Updated
April 9, 2019
Sponsor
Tokyo Medical and Dental University
1. Study Identification
Unique Protocol Identification Number
NCT02332356
Brief Title
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Official Title
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Medical and Dental University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease, Inflammatory Bowel Diseases, Disease Attributes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
step up
Arm Type
Active Comparator
Arm Description
Procedure: MREC patients receive therapeutic step up
Arm Title
observation step up
Arm Type
No Intervention
Arm Title
step down
Arm Type
Active Comparator
Arm Description
Procedure: MREC patients receive therapeutic step down
Arm Title
observation step down
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
azathioprine or adalimumab and infliximab
Primary Outcome Measure Information:
Title
The rate of clinical remission at 104 weeks.
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
The rate of hospitalization and operation
Time Frame
104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toshimitsu Fujii
Phone
+81 3 58035877
Email
tfujii.gast@tmd.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshimitsu Fujii
Organizational Affiliation
Tokyo Medical and Dental University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshimitsu Fujii
Phone
+81 3 58035877
Email
tfujii.gast@tmd.ac.jp
12. IPD Sharing Statement
Citations:
PubMed Identifier
24732015
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.
Results Reference
background
PubMed Identifier
21484957
Citation
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.
Results Reference
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Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
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