UMIN-CTR Clinical Trial

Basic information
Public title	Study for new biomarker development for diagnosis and evaluation of disease activity in juvenile rheumatic disease
Acronym	Biomarker for juvenile rheumatic disease
Scientific Title	Study for new biomarker development for diagnosis and evaluation of disease activity in juvenile rheumatic disease
Scientific Title:Acronym	Biomarker for juvenile rheumatic disease
Region	Japan

Condition
Condition	juvenile idiopathic arthritis, juvenile systemic erythematosus, juvenile dermatomyositis, juvenile Sjoegren syndrome, juvenile connective tissue disease, Henoch-Schonlein purpura, juvenile polyarteritis nodosa, juvenile aortitis syndrome, ulcerative colitis, Crohn's disease
Classification by specialty	Clinical immunology Pediatrics Laboratory medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of PTX3 in assessment of remission or flare up of Pediatric rheumatic disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to establish significant parameters that help to distinguish remission from flare of diseases, and identify cut off values
Key secondary outcomes	PTX3 versus C-reactive protein PTX3 versus sLOX-1 PTX3 versus disease activity sLOX-1 versus disease activity PTX3 with steroid dose PTX3 with hospitalization

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	25 years-old >
Gender	Male and Female
Key inclusion criteria	Pediatric rheumatic disease patients
Key exclusion criteria	patient who did not fulfill the rheumatic disease criteria. patients for whom data were insufficient.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Kitoh
Organization	Aichi Medical University Hospital
Division name	Pediatrics
Zip code	480-1195
Address	1-1 Yazako Karimata, Nagakute
TEL	0561-62-3311
Email	tkitoh@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Kitoh
Organization	Aichi Medical University
Division name	Pediatrics
Zip code	4801195
Address	Department of Pediatrics
TEL	+81561623311
Homepage URL
Email	tkitoh@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Hospital
Institute
Department

Funding Source
Organization	Non profit foundation Aichi Medical University "Aikei-Kai"
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Pediatrics, Kanazawa University Department of Pediatrics, Kyoto University Hospital Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Kobe Gakuin University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aichi Medical School
Address	1-1 Yazaka Karimata
Tel	+81561623311
Email	tkitoh@aichi-med-u.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

聖隷浜松病院小児科（静岡県）Department of Pediatrics, Seirei Hamamatsu General Hospital(Shizuoka) 浜松医科大学小児科（静岡県）Department of Pediatrics, Hamamatsu University of Medicine (Shizuoka) あいち小児保健医療総合センター感染免疫科（愛知県）Department of Infection and Immunology, Aichi Children's Health and Medical Center (Aichi) 岐阜大学大学院医学系研究科小児病態学（岐阜県）Department of Pediatrics, Graduate School of Medicine Gifu University (Gifu) 国立病院機構 三重病院小児科（三重県）Department of Pediatrics, National Mie Hospital (Mie) 金沢大学病院小児科（石川県）Department of Pediatrics, Kanazawa University Hospital　(Ishikawa) 滋賀県立小児保健医療センター血液・リウマチ科（滋賀県）Department of Hematology/ Rheumatology, Shiga Medical Center for Children (Shiga) 京都大学医学部附属病院小児科（京都府） Department of Pediatrics, Kyoto University Hospital (Kyoto) 兵庫県立こども病院アレルギー・リウマチ科（兵庫県）Hyogo Children’s Hospital (Hyogo)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 09 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	2014 Year 05 Month 25 Day
Date of IRB	2014 Year 08 Month 10 Day
Anticipated trial start date	2014 Year 10 Month 14 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	IRB approoved

Management information
Registered date	2014 Year 05 Month 30 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016438