UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044286
Receipt number 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 2021/12/20 18:19:31

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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 or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2021 Year 07 Month 01 Day

Date of IRB

2021 Year 07 Month 01 Day

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 12 Month 20 Day



Link to view the page

Value
https://center6.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