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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026844
Receipt No. R000030811
Scientific Title Ulcerative colitis- real world study for the effects of biologics, anti-TNF alpha- golimumab in remission- induction and maintenance- (UC- BINGO) study
Date of disclosure of the study information 2017/06/01
Last modified on 2019/04/04

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Basic information
Public title Ulcerative colitis- real world study for the effects of biologics, anti-TNF alpha- golimumab in remission- induction and maintenance- (UC- BINGO) study
Acronym UC- BINGO study
Scientific Title Ulcerative colitis- real world study for the effects of biologics, anti-TNF alpha- golimumab in remission- induction and maintenance- (UC- BINGO) study
Scientific Title:Acronym UC- BINGO study
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the rate of clinical response and clinical remission in UC- patients refractory to conventional or infliximab and/ or adalimumab, and biomarkers of golimumab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical response rate at week 6
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
15 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria UC- patients whose age is 15 years old and more, and 70 years ld and less.
UC- patients refractory to conventional therapy
UC- patiens refractory to infliximab and/ or adalimumab
Key exclusion criteria Patients who has contraindication of golimumab
Patients in pregnancy and lactation period
Patients who has and had malignancy
Patients who don nott have informed conents
Patients determined not to be suitable for this study by physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name SHINGO
Middle name
Last name KATO
Organization Saitama Medical University, Saitama Medical Center
Division name Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3564
Email skato@saitama-med.ac.jp

Public contact
Name of contact person
1st name SHINGO
Middle name
Last name KATO
Organization Saitama Medical University, Saitama Medical Center
Division name Gastroenterology and Hepatology
Zip code 350-8550
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, Saitama Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University, Saitama Medical Center
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, Saitama, Japan
Tel 049-228-3500
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
2017 Year 06 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
2017 Year 04 Month 30 Day
Date of IRB
2017 Year 05 Month 11 Day
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030811

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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