UMIN-CTR Clinical Trial

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

Contact us.