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

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 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

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

Value
https://center6.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