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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034662
Receipt No. 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 2019/04/27

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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
Institute Tohoku University Hospital
Division of Gastroenterology
Institute
Department

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 Open public recruiting
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
2023 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
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.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


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