UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039696
Receipt number R000045278
Scientific Title Measurement of antibody titers against infectious viral diseases in patients with inflammatory bowel disease treated with immunosuppressive agents : a multicenter study
Date of disclosure of the study information 2020/03/05
Last modified on 2023/03/09 10:09:21

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Basic information

Public title

Measurement of antibody titers against infectious viral diseases in patients with inflammatory bowel disease treated with immunosuppressive agents : a multicenter study

Acronym

Antibody titers against infectious viral diseases in immunocompromised IBD

Scientific Title

Measurement of antibody titers against infectious viral diseases in patients with inflammatory bowel disease treated with immunosuppressive agents : a multicenter study

Scientific Title:Acronym

Antibody titers against infectious viral diseases in immunocompromised IBD

Region

Japan


Condition

Condition

Crohn's disease, ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure antibody titers against infectious viral diseases in patients with inflammatory bowel disease who are treated with immunosuppressive agents
To optimize treatments and to develop an appropriate vaccine strategy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

seronegative rates of infectious viral diseases (measles, mumps, rubella, varicella zoster, cytomegalovirus and Epstein-Barr virus)

Key secondary outcomes

seronegative rates of infectious viral diseases stratified according to disease type (Crohn's disease or ulcerative colitis), age, disease duration or type of immunosuppressive agents


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with confirmed diagnosis of Crohn's disease or ulcerative colitis
Patients who are or will be treated with immunosuppressive agents (prednisolone, thiopurine, methotrexate, anti-TNF agents, ustekinumab, tofacitinib, vedolizumab, etc.)
Patients aged 20 or more (including patients aged 16 to under 20 with parental consent)

Key exclusion criteria

Patients without confirmed diagnosis of Crohn's disease or ulcerative colitis
Patients under 16 years
Patients judged as unsuitable for the participation by physicians

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Hisashi
Middle name
Last name Shiga

Organization

Tohoku University Hospital

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo, Aoba, Sendai, Japan

TEL

022-717-7171

Email

shiga@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Hisashi
Middle name
Last name Shiga

Organization

Tohoku University Hospital

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo, Aoba, Sendai, Japan

TEL

022-717-7171

Homepage URL


Email

shiga@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

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

Ethics Committee Tohoku University Hospital

Address

1-1 Seiryo, Aoba, Sendai, Japan

Tel

022-728-4105

Email

cirb@rinri.hosp.tohoku.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

2020 Year 03 Month 05 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

500

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

Main results already published

Date of protocol fixation

2019 Year 10 Month 11 Day

Date of IRB

2019 Year 11 Month 13 Day

Anticipated trial start date

2019 Year 11 Month 13 Day

Last follow-up date

2024 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

a multicenter cohort study


Management information

Registered date

2020 Year 03 Month 04 Day

Last modified on

2023 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name