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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002341
Receipt No. R000002868
Scientific Title Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease
Date of disclosure of the study information 2009/08/18
Last modified on 2014/02/17

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Basic information
Public title Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease
Acronym Biomarkers of Crohn's disease
Scientific Title Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease
Scientific Title:Acronym Biomarkers of Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate biomarkers for predicting effectiveness of Infliximab for the treatment of the patients with Crohn's disease
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of 50 cytokines by multiplex array system and clinica activity of Crohn's disease
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Crohn's disease elder than 16 years old who need treatments with Infliximab and gave written informed consent.
Key exclusion criteria Patients with Crohn's disease who are not applicable to Infliximab treatment and who do not give written informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Iijima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2- Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 81-6-6879-3621
Email hiijima@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Iijima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871
TEL +81-6-6879-3621
Homepage URL http://www.med.osaka-u.ac.jp/pub/gh/index.htm
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Intractable Diseases Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 18 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 Completed
Date of protocol fixation
2009 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum samples from patients with Crohn's disease are collected before, 2 wks, 6 wks, 6Mos, 12Mos after the treatemt with Infliximab and are analyzed for the expressions of cytokines, chemokine and adhesion molecules by Bio-Plex assay.

Management information
Registered date
2009 Year 08 Month 17 Day
Last modified on
2014 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002868

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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