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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044286
Receipt No. R000050582
Scientific Title Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis
Date of disclosure of the study information 2021/07/01
Last modified on 2021/05/21

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Basic information
Public title Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis
Acronym UC-EXTEND Study
Scientific Title Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis
Scientific Title:Acronym UC-EXTEND Study
Region
Japan

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

Objectives
Narrative objectives1 Persistence and safety of switching ustekinumab maintenance therapy every 8 to 12 weeks in UC patients with clinical remission 26weeks and more.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Persistence rate until 1 year
Key secondary outcomes

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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria UC patients with clinical remission treated by ustekinumab 90mg subcutaneous every 8 weeks
Key exclusion criteria Patients of contraindication of ustekinumab
Patients with pregnancy or lactating
Patients without informed consent
Patients with previous or ongoing malignancy
Patients with colectomy
Patients who is not appropriate for this study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code 3508550
Address 1981, Kamoda, Kawagoe City, Saitama, Japan
TEL 0492283564
Email katoshin007@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code 3508550
Address 1981, Kamoda, Kawagoe City, Saitama, Japan
TEL 0492283564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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 IRB of Saitama Medical Center
Address 1981, Kamoda, Kawagoe City, Saitama, Japan
Tel 049-228-3902
Email smcrinri@saitama-med.ac.jp

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
2021 Year 07 Month 01 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
2021 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Intermediate analysis will be performed at the timing of entry of 10 and more patients. Finally this study will be continued until 3 years. However, we will make presentations in scientific meetings and/or published paper about the data until 1 year.

Management information
Registered date
2021 Year 05 Month 21 Day
Last modified on
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050582

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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