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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name