UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034662
Receipt number R000039407
Scientific Title Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study
Date of disclosure of the study information 2018/10/29
Last modified on 2022/11/08 18:06:52

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Basic information

Public title

Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study

Acronym

Efficacy of tight control management on Japanese CD patients treated with biologics

Scientific Title

Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study

Scientific Title:Acronym

Efficacy of tight control management on Japanese CD patients treated with biologics

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether tight control management based on clinical symptoms combined with biomarkers results in better outcome
To identify optimal biomarkers and their optimal standards for tight control management from clinical symptoms, serum or fecal biomarkers

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical remission and mucosal healing rates 52 weeks after the treatment with biologics

Key secondary outcomes

Rate of major adverse outcomes (hospitalization, surgery, discontinuation due to treatment failure)
Factors associated with clinical remission, mucosal healing or major adverse 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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Ileal, colonic, or ileocolonic Crohn's disease patients treated with biologics (anti-TNF agents, ustekinumab or vedolizumab)

Key exclusion criteria

1) Patients with severe infection (sepsis, etc.)
2) Patients with active tuberculosis
3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, ustekinumab, or vedolizumab, or the protein of mouse origin
4) Patients with demyelinating disease (multiple sclerosis, etc.) or with history of demyelinating disease
5) Patients with congestive heart failure
6) Patients treated with two or more biologics in combination
7) Patients under 16 years old
8) Patients judged as inappropriate by physicians

Target sample size

100


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
Division of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None

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

Tohoku University School of Medicine, Ethics Committee

Address

2-1 Seiryo, Aoba, Sendai, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.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

2018 Year 10 Month 29 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

Main results already published

Date of protocol fixation

2018 Year 10 Month 11 Day

Date of IRB

2018 Year 10 Month 11 Day

Anticipated trial start date

2018 Year 10 Month 29 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 10 Month 26 Day

Last modified on

2022 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039407


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name