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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038737
Receipt No. R000044167
Scientific Title A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/29

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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


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