UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026844 |
|---|---|
| Receipt number | 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 | 2021/12/20 18:21:41 |
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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
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
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, Saitama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030811
