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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043071
Receipt No. R000049097
Scientific Title RAre Disease DAta Registry of Japan[60]
Date of disclosure of the study information 2021/02/15
Last modified on 2021/01/21

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Basic information
Public title Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry
Acronym Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry
Scientific Title RAre Disease DAta Registry of Japan[60]
Scientific Title:Acronym RADDAR-J [60]
Region
Japan

Condition
Condition Systemic lupus erythematosus
Antiphospholipid syndrome
Polymyositis / Dermatomyositis
Mixed connective tissue disease
Sjogren's syndrome
Juvenile idiopathic arthritis
Adult Still's disease
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To accumulate clinical information of patients with the target autoimmune disease.
To examine the evaluation items continuously and in long-term.
To elucidate the natural history and prognostic factors of the target disease.
To establish new treatment strategy for the target disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes death and relapse during 10 years
Key secondary outcomes Lung, renal, cardiovascular, pulmonary artery, neurological, and skin lesions due to underlying autoimmune diseases. Macrophage activation syndrome.
Adverse events(malignancy, infection requiring hospitalization, cardio-cerebrovascular diseases, bone fracture, drug eruption).
Severity and disease activity of underlying autoimmune diseases. Patient-reported outcome. EQ-5D-5L.

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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed with the autoimmune diseases according to the diagnostic criteria of the Ministry of Health, Labor and Welfare.
Patients who consented to participate in the study in writing.
Key exclusion criteria Patients judged to be inappropriate as a target by the judgment of researchers.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name masaaki
Middle name
Last name mori
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Lifetime Clinical Immunology
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku Tokyo
TEL 0358034677
Email mori.phv@tmd.ac.jp

Public contact
Name of contact person
1st name takahiko
Middle name
Last name sugihara
Organization St. Marianna University School of Medicine
Division name Division of Rheumatology and Allergy, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email takahikosugihara03240925@gmail.com

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4642
Email ethcom@kuhp.kyoto-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

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 15 Day
Date of IRB
2020 Year 12 Month 15 Day
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The primary and secondary endpoints were observed every year for 10 years.

Management information
Registered date
2021 Year 01 Month 21 Day
Last modified on
2021 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049097

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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