Unique ID issued by UMIN | UMIN000043071 |
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Receipt number | R000049097 |
Scientific Title | RAre Disease DAta Registry of Japan[60] |
Date of disclosure of the study information | 2021/02/15 |
Last modified on | 2023/01/23 10:56:13 |
Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry
Construction of Rare Disease Data Registry of Japan for autoimmune disease, and long-term nationwide multi-institutional researches utilizing the registry
RAre Disease DAta Registry of Japan[60]
RADDAR-J [60]
Japan |
Systemic lupus erythematosus
Antiphospholipid syndrome
Polymyositis / Dermatomyositis
Mixed connective tissue disease
Sjogren's syndrome
Juvenile idiopathic arthritis
Adult Still's disease
Clinical immunology | Pediatrics |
Others
NO
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.
Safety,Efficacy
Others
Pragmatic
Not applicable
death and relapse during 10 years
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.
Observational
1 | years-old | <= |
100 | years-old | >= |
Male and Female
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.
Patients judged to be inappropriate as a target by the judgment of researchers.
5000
1st name | masaaki |
Middle name | |
Last name | mori |
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Department of Lifetime Clinical Immunology
113-8519
1-5-45 Yushima, Bunkyo-ku Tokyo
0358034677
mori.phv@tmd.ac.jp
1st name | takahiko |
Middle name | |
Last name | sugihara |
St. Marianna University School of Medicine
Division of Rheumatology and Allergy, Department of Internal Medicine
216-8511
2-16-1, Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
044-977-8111
takahikosugihara03240925@gmail.com
Ministry of Health, Labour and Welfare
Ministry of Health, Labour and Welfare
Japanese Governmental office
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
075-753-4642
ethcom@kuhp.kyoto-u.ac.jp
NO
2021 | Year | 02 | Month | 15 | Day |
Unpublished
168
Open public recruiting
2020 | Year | 12 | Month | 15 | Day |
2020 | Year | 12 | Month | 15 | Day |
2021 | Year | 02 | Month | 15 | Day |
2031 | Year | 03 | Month | 31 | Day |
The primary and secondary endpoints were observed every year for 10 years.
2021 | Year | 01 | Month | 21 | Day |
2023 | Year | 01 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049097
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