UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Acronym	A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Scientific Title	A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Scientific Title:Acronym	A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Region	Japan

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

Objectives
Narrative objectives1	Clarify the positioning of various biologics
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	The rates of remission maintenance rates at 52 weeks, clinical activity index (partial mayo score) 2 or less
Key secondary outcomes	The rates of induction remission at 14 weeks, , clinical activity index (partial mayo score) 2 or less The rates of maintenance rates at 104 weeks, , clinical activity index (partial mayo score) 2 or less colectomy-free rate at 52 weeks mucosal healing rate at 52 weeks, endoscopic mayo score 0 or 1

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	15 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	moderate to severe ulcerative colitis receiving biologics
Key exclusion criteria	severe infection Patients who have undergone or consider abdominal surgery Patients who are considered ineligible
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Yamada
Organization	Sakura medical center, Toho university
Division name	interal medicine
Zip code	285-0841
Address	564-1,Shimoshizu, Sakura, Chiba, Japan
TEL	0434628811
Email	taro-dog@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Yamada
Organization	Sakura medical center, Toho university
Division name	internal medicine
Zip code	285-0841
Address	564-1,Shimoshizu, Sakura, Chiba, Japan
TEL	0434628811
Homepage URL
Email	taro-dog@sakura.med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

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	Sakura medical center, Toho university
Address	564-1,Shimoshizu, Sakura, Chiba, Japan
Tel	0434628811
Email	taro-dog@sakura.med.toho-u.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	2019 Year 12 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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2020 Year 01 Month 10 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2021 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 12 Month 10 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	Publication of academic societies

Management information
Registered date	2019 Year 11 Month 29 Day
Last modified on	2019 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044167

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.