UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017781 |
|---|---|
| Receipt number | R000020594 |
| Scientific Title | Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease |
| Date of disclosure of the study information | 2015/06/02 |
| Last modified on | 2023/12/08 10:49:11 |
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Basic information
Public title
Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease
Acronym
MREC study
Scientific Title
Therapeutic optimization study based on MR enterocolonography in patients with Crohn's disease
Scientific Title:Acronym
MREC study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with 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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The primary endpoint is the rate of clinical remission(CDAI<150) at 104 weeks.
Key secondary outcomes
CDAI, operation, hospitalizasion, SES-CD, anctivity of MREC and MaRIA, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Step up active: step up arm:
patients receive therapeutic step up
Interventions/Control_2
No Intervention: Standard care arm
Interventions/Control_3
Step down active: step down arm:
patients receive therapeutic step down
Interventions/Control_4
No Intervention: Standard care arm
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key 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)
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Fujii |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
TEL
03-5803-5877
tfujii.gast@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Fujii |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
TEL
03-5803-5877
Homepage URL
tfujii.gast@tmd.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grants-in-Aid for Scientific Research
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Clinical Reserch Center
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo Japan
Tel
03-5803-4575
tiken.crc@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02332356
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）、北海道大学病院（北海道）、山梨大学医学部附属病院（山梨県）、武蔵野赤十字病院（東京都）、草加市立病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
56
Results
NA
Results date posted
| 2023 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020594
