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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039295
Receipt No. R000044820
Scientific Title JPVAS prospective cohort study for vasculitides [RADDAR-J [22] ]
Date of disclosure of the study information 2020/01/29
Last modified on 2021/01/28

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Basic information
Public title JPVAS prospective cohort study for vasculitides
Acronym JPVAS prospective cohort study for vasculitides
Scientific Title JPVAS prospective cohort study for vasculitides [RADDAR-J [22] ]
Scientific Title:Acronym JPVAS prospective cohort study for vasculitides
Region
Japan

Condition
Condition microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA), Takayasu arteritis (TAK), giant cell arteritis (GCA)
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To accumulate clinical information of patients with vasculitides longitudinally for the purpose of elucidating the natural history and prognostic factors and to contribute to the development and the establishment of novel treatment of vasculitides in the future.
Basic objectives2 Others
Basic objectives -Others To establish the long-term registry for vasculitide
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BVAS remission rate at one year, time to recurrence, mortality rate at five years, serious infection
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who were diagnosed as having either MPA, GPA, EGPA, TAC, or GCA according to the diagnostic criteria of Ministry of Health, Labour and Welfare
2. Subjects who provided written informed consent
Key exclusion criteria Subjects who were judged ineligible by investigators
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Harigai
Organization Tokyo Women's Medical University Hospital
Division name Department of Rheumatology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-5269-1725
Email harigai.masayoshi@twmu.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Higuchi
Organization Tokyo Women's Medical University Hospital
Division name Department of Rheumatology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-5269-1725
Homepage URL
Email higuchi.tomoaki@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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, Japan
Tel 075-753-4680
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 東京女子医科大学病院(東京都)、杏林大学医学部腎臓・リウマチ膠原病内科学教室(東京都)、宮崎大学医学部医学科血液・血管先端医療学講座(宮崎県)、東京大学医学部附属病院(東京都)、北海道大学大学院医学研究院(北海道)、埼玉医科大学総合医療センターリウマチ・膠原病内科(埼玉県)、東北大学病院(宮城県)、東北医科薬科大学病院(宮城県)、帝京大学医学部附属病院(東京都)、岡山大学大学院医歯薬学総合研究科腎・免疫・内分泌代謝内科学講座(岡山県)、九州大学病院(福岡県)、東京医科歯科大学医学部附属病院(東京都)、慶応義塾大学病院(東京都)、順天堂大学医学部附属順天堂病院(東京都)、香川大学医学部血液免疫呼吸器内科学講座(香川県)、青梅市立総合病院(東京都)、国立循環器病研究センター研究所血管生理学部(大阪府)、東邦大学医学部内科学講座膠原病学分野(東京都)、愛媛大学大学院医学系研究科(愛媛県)、旭川医科大学耳鼻咽喉科・頭頸部外科学教室(北海道)、自治医科大学医学部内科学講座呼吸器内科学部門(栃木県)、和歌山県立医科大学医学部リウマチ膠原病科学講座(和歌山)、京都大学医学部附属病院(京都府)、金沢大学医薬保健研究域医学系(石川県)、日本大学小児科(東京都)、横浜市立大学大学院医学研究科発生成育小児医療学(神奈川県)、東京都健康長寿医療センター(東京都)、公益財団法人田附興風会医学研究所北野病院(大阪府)、国立成育医療研究センター(東京都)、浜松医科大学第三内科(静岡県)、筑波大学医学医療系臨床医学域腎臓内科学(茨城県)、長崎大学大学院医歯薬学総合研究科先進予防医学共同専攻リウマチ・膠原病内科学分野(長崎県)、山口大学大学院医学系研究科神経内科学(山口県)、独立行政法人地域医療機能推進機構中京病院JCHO中京病院(愛知県)、秋田大学医学部血液・腎臓・リウマチ内科(秋田県)、国立病院機構相模原病院アレルギー科(神奈川県)、聖マリアンナ医科大学附属病院(神奈川県)、岩手県立中央病院(岩手県)、千葉大学大学院医学研究院アレルギー・臨床免疫学(千葉県)、名古屋市立大学大学院医学研究科呼吸器・免疫アレルギー内科学(愛知県)、(株)日立製作所ひたちなか総合病院(茨城県)、島根大学医学部内科学講座・内科学第三(島根県)、岡山済生会総合病院(岡山県)、県立広島病院(広島県) 、高知県立幡多けんみん病院(高知県)、藤田医科大学・医学部腎臓内科学(愛知県)、群馬大学・大学院医学系研究科(群馬県)、あいち小児保健医療総合センター 免疫アレルギーセンター(愛知県)、岐阜大学医学部(岐阜県)、新潟大学腎・膠原病内科学分野(新潟県)、聖路加国際病院(東京都)、国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 29 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
2019 Year 10 Month 01 Day
Date of IRB
2020 Year 04 Month 08 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2035 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multi-center registry study

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2021 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044820

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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