UMIN-CTR Clinical Trial

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	Enrolling by invitation
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	2025 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	2021 Year 12 Month 20 Day

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