UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015008
Receipt number R000017455
Scientific Title Examination of the necessity of anti-TNF maintenance therapy for ulcerative colitis
Date of disclosure of the study information 2014/08/31
Last modified on 2022/10/16 22:55:31

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Basic information

Public title

Examination of the necessity of anti-TNF maintenance therapy for ulcerative colitis

Acronym

EXAMU study

Scientific Title

Examination of the necessity of anti-TNF maintenance therapy for ulcerative colitis

Scientific Title:Acronym

EXAMU study

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the discontinuation of anti-TNF maintenance therapy for ulcerative colitis patients with clinical remission

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Remission rate after the discontinuation of anti-TNF maintenance therapy

Key secondary outcomes

The feature of ulcerative colitis patients with clinical remission after the discontinuation of anti-TNF maintenance therapy


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Ulcerative colitis patients with clinical remission and mucosalhealing for anti-TNF maintenance therapy and without steroid

Key exclusion criteria

Ulcerative colitis patients without clinical remission. Patients under pregnancy and breast-feeding or the female patient that may have become pregnant. Patients judged to be disqualified .

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Yoshida

Organization

Ofuna Chuo Hospita

Division name

Center for GI/IBD

Zip code


Address

Ofuna Kamakura, Kanagawa 247-0056 Japan

TEL

81-46-745-2111

Email

atushi.y@kza.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Yoshida

Organization

Ofuna Chuo Hospital

Division name

Center for GI/IBD

Zip code


Address

Ofuna Kamakura, Kanagawa 247-

TEL

+81-46-745-2111

Homepage URL


Email

atushi.y@kza.biglobe.ne.jp


Sponsor or person

Institute

Center for GI/IBD

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 31 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

In 2018, I will report the research results at the academic conference.

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

Completed

Date of protocol fixation

2014 Year 08 Month 08 Day

Date of IRB

2014 Year 08 Month 08 Day

Anticipated trial start date

2014 Year 08 Month 31 Day

Last follow-up date

2017 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded



Other

Other related information

Examination of the necessity of anti-TNF maintenance therapy for ulcerative colitis


Management information

Registered date

2014 Year 08 Month 31 Day

Last modified on

2022 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name