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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009678
Receipt No. R000011311
Scientific Title The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients
Date of disclosure of the study information 2013/01/15
Last modified on 2014/07/02

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Basic information
Public title The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients
Acronym The investigation of drug withdrawal for ulcerative colitis patients
Scientific Title The investigation of drug withdrawal with immunosuppressant and biologics for ulcerative colitis patients
Scientific Title:Acronym The investigation of drug withdrawal for ulcerative colitis patients
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate if immunosuppressant or biologics are necessary for maintenance therapy for the patients of ulcerative colitis who are diagnosed as remission phase. We also investigate if clinical symptomatic remission or endoscopic mucosal healing are useful indicator for standard of discontinue of these drugs.
Basic objectives2 Others
Basic objectives -Others Observation study for discontinue of immunosuppressant or biologics for maintenance of remission of ulcerative colitis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopic findings for 12, 24, 36 months from the start of this study.
Key secondary outcomes Clinical activity index (CAI) for every 3 month from the start of this study.

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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria The patients of ulcerative colitis who are maintained by using biologics and/or immunosuppressant, and who are diagnosed as clinical remission and confirmed as mucosal healing by endoscopy. All patients should be agreed the burden of this study.
Key exclusion criteria The patients who are impaired consciousness and do not have the ability of agreement.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL 075-251-5519
Homepage URL
Email takatomo@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 京都府立医科大学(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 15 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 Preinitiation
Date of protocol fixation
2012 Year 12 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective and case controlled study. The patients is in remission phase of ulcerative colitis who are treated by immunosuppressant or biologics.

Management information
Registered date
2013 Year 01 Month 02 Day
Last modified on
2014 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011311

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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