UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043071
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

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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 or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



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

168

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

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

2023 Year 01 Month 23 Day



Link to view the page

Value
https://center6.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