UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060218 |
|---|---|
| Receipt number | R000068645 |
| Scientific Title | Pediatric Rheumatology International Collaboration Unit Registry |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/08 23:38:56 |
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Basic information
Public title
Pediatric Rheumatology International Collaboration Unit Registry
Acronym
PRICURE
Scientific Title
Pediatric Rheumatology International Collaboration Unit Registry
Scientific Title:Acronym
PRICURE
Region
| Japan |
Condition
Condition
Juvenile idiopathic arthritis(JIA), Systemic lupus erythematosus(SLE), Juvenile dermatomyositis(JDM), Sjogren's syndrome(SS), Mixed connective tissue disease (MCTD), Systemic sclerosis(SSc), Behcet's disease, Vasculitis syndromes, Autoinflammatory diseases
Classification by specialty
| Clinical immunology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to systematically collect and aggregate epidemiological data on pediatric rheumatic diseases, which are classified as rare disorders, and to utilize these data to improve the research infrastructure for evaluating disease characteristics, as well as the effectiveness and safety of treatments. Through these efforts, the study seeks to facilitate the advancement of clinical research and therapeutic development in pediatric rheumatology.
Basic objectives2
Others
Basic objectives -Others
･To describe the epidemiological characteristics of pediatric rheumatic diseases.
･To evaluate the effectiveness and safety of existing treatments.
･To establish a research infrastructure that facilitates future clinical studies and therapeutic development.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core clinical data including disease characteristics, disease activity, treatment patterns, treatment effectiveness, adverse events, and clinical outcomes obtained through retrospective chart review.
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with a pediatric-onset rheumatic disease and treated at our institution, regardless of disease duration.
2) Patients who have been diagnosed with one or more of the following conditions:Juvenile idiopathic arthritis (JIA), Systemic lupus erythematosus (SLE), Juvenile dermatomyositis (JDM), Sjogren's syndrome (SS), Mixed connective tissue disease (MCTD), Systemic sclerosis (SSc), Behcet's disease, Vasculitis syndromes, Autoinflammatory diseases.
Key exclusion criteria
Patients (or their legal guardians) who decline participation in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Narazaki |
Organization
Nippon Medical School
Division name
Pediatrics
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
pricure@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Narazaki |
Organization
Nippon Medical School
Division name
Pediatrics
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
pricure@nms.ac.jp
Sponsor or person
Institute
Nippon Medical Shcool
Institute
Department
Personal name
Funding Source
Organization
Pediatric Rheumatology Association of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethics Committee, Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
| 2026 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data obtained in this study may be used for future research projects (secondary use).
Secondary use of data is permitted only if all of the following conditions are met:
1) The proposed research project has been approved by the ethics committee of the institution where the principal investigator of the secondary research is affiliated; and
2) the project has been reviewed and approved through the procedures established by both the Academic Committee and the Ethics Committee of the Pediatric Rheumatology Association of Japan (PRAJ).
Data provided for secondary use shall be limited to the scope approved in the application submitted by the secondary data user to the PRAJ Academic Committee.
Approved data will be provided as a digitally protected file under strict password management.
Consent for secondary use has already been obtained through the opt-out method for this study; therefore, no additional consent from participants is required.
Management information
Registered date
| 2025 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068645
