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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017781
Receipt No. 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 2019/06/05

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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

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
Email 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
Email tfujii.gast@tmd.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology
Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2019 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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