UMIN-CTR Clinical Trial

Basic information
Public title	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Acronym	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Scientific Title	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Scientific Title:Acronym	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether endoscopic mucosal healing can be used to determine the optimization of ustekinumab dosing intervals in patients with ulcerative colitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	endoscopic therapeutic effects and clinical findings after UST administration at week 28 to 32.
Key secondary outcomes	Lichtiger index, white blood cells, platelets, albumin, C-reactive protein, erythrocyte sedimentation rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients aged 20 years or older at the time of obtaining the consent form. 2. Patients with ulcerative colitis who received ustekinumab. 3. Ulcers that have already started treatment with ustekinumab but have not undergone endoscopy after treatment within 24 weeks
Key exclusion criteria	1.Patients judged by the principal investigator to be inappropriate as subjects 2.Patients without discernment 3.Patients who cannot obtain written consent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name YUKA Middle name Last name FUKUO
Organization	JUNTENDO UNIVERSITY NERIMA HOSPITAL
Division name	Gastroenterology
Zip code	1778521
Address	3-1-10 Takanodai Nerima-ku Tokyo
TEL	03-5923-3111
Email	yfukuo@juntendo.ac.jp

Public contact
Name of contact person	1st name YUKA Middle name Last name FUKUO
Organization	JUNTENDO UNIVERSITY NERIMA HOSPITAL
Division name	Gastroenterology
Zip code	1778521
Address	3-1-10 Takanodai Nerima-ku Tokyo
TEL	03-5923-3111
Homepage URL
Email	yfukuo@juntendo.ac.jp

Sponsor
Institute	JUNTENDO UNIVERSITY NERIMA HOSPITAL
Institute
Department

Funding Source
Organization	nothing
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	JUNTENDO UNIVERSITY NERIMA HOSPITAL
Address	3-1-10 Takanodai Nerima-ku Tokyo
Tel	0359233111
Email	yfukuo@juntendo.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	2022 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2020 Year 10 Month 08 Day
Date of IRB	2020 Year 10 Month 08 Day
Anticipated trial start date	2020 Year 10 Month 08 Day
Last follow-up date	2025 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	2022 Year 01 Month 16 Day
Last modified on	2022 Year 01 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053213

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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