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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002864
Receipt No. R000003494
Scientific Title Association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Date of disclosure of the study information 2009/12/10
Last modified on 2010/06/09

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Basic information
Public title Association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Acronym Association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Scientific Title Association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Scientific Title:Acronym Association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Region
Japan

Condition
Condition juvenile idiopathic arthritis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate association of HLA-DR gene polymorphism and rheumatoid arthritis associated genes (PADI4 and IRF5 polymorphisms) with juvenile idiopathic arthritis.
Basic objectives2 Others
Basic objectives -Others pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of juvenile idiopathic arthritis
Key secondary outcomes Subgroup analysis based on (1) subtype of JIA (systemic onset or oligoarticular/polyarticular onset), (2) response to therapy, (3) the level of anti-citrullinated peptide antibodies, rheumatoid factor, antinuclear antibody, or matrix metalloproteiase-3, (4) family history of rheumatic disease and autoimmune disease,(5) complications such as macrophage activation syndrome and uveitis

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

Not applicable
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria The patients with juvenile idiopathic arthritis treated in our hospital and with obtained prior written informed consent from patients and/or their parents.
Key exclusion criteria The patient judged as improper case for enrollment in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakatsu Yanagimachi
Organization Yokohama City University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masakatsu Yanagimachi
Organization Yokohama City University School of Medicine
Division name Department of Pediatrics
Zip code
Address
TEL 045-787-2671
Homepage URL
Email

Sponsor
Institute Department of Pediatrics, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Health and labour Sciences Research Grants
Organization
Division
Category of Funding Organization
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 12 Month 10 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 No longer recruiting
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 06 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information Case-control study

Management information
Registered date
2009 Year 12 Month 09 Day
Last modified on
2010 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003494

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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