UMIN-CTR Clinical Trial

Basic information
Public title	Japanese nation-wide prospective observational study on the current state and efficacy of therapeutics for large vessel vasculitis, -Takayasu's arteritis and Giant cell arteritis-
Acronym	Japanese nation-wide prospective observational study on the current state and efficacy of therapeutics for large vessel vasculitis
Scientific Title	Japanese nation-wide prospective observational study on the current state and efficacy of therapeutics for large vessel vasculitis, -Takayasu's arteritis and Giant cell arteritis-
Scientific Title:Acronym	Japanese nation-wide prospective observational study on the current state and efficacy of therapeutics for large vessel vasculitis
Region	Japan

Condition
Condition	Large Vessel Vasculitis (Takayasu's arteritis, Giant cell arteritis)
Classification by specialty	Cardiology Clinical immunology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the current state and efficacy of therapeutics for large vessel vasculitis including Takayasu's arteritis and Giant cell arteritis
Basic objectives2	Others
Basic objectives -Others	To elucidate the agenda of the current diagnostic criteria and classification for large vessel vasculitis including Takayasu's arteritis and Giant cell arteritis
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the remission rate of Takayasu's arteritis and Giant cell arteritis
Key secondary outcomes	1) survival rate 2) cause of death 3) responder rate of the therapy 4) relapse rate 5) incidence rate of the infectious disease and the analysis of its risk factor 6) concordance rate of current diagnostic criteria and classification of large vessel vasculitis 7) pathological condition of Takayasu's arteritis and Giant cell arteritis 8) identification of the candidate of new biomaker of large vessel vasculitis 9) identification of the new diagnostic imaging method

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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Newly diagnosed patients with large vessel vasculitis including Takayasu's arteritis and Giant cell arteritis
Key exclusion criteria	1) the patients with Buerger's disease 2) the patients with malignant disease 3) the patients who their primary doctors consider as inappropriate 4) the patients who disagree to participate in this study
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Hirofumi Middle name Last name Makino
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Medicine and Clinical Sciences
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	086-235-7235
Email	hauchida@md.okayama-u.ac.jp

Public contact
1st name of contact person	1st name Haruhito Middle name A Last name Uchida
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Medicine and Clinical Sciences
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	086-235-7235
Homepage URL
Email	hauchida@md.okayama-u.ac.jp

Sponsor
Institute	The Specified Disease Treatment Research Program
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethics Committee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel	086-235-6503
Email	mae6605@adm.okayama-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	岡山大学病院（岡山県）、川崎医科大学病院（岡山県）、東京医科歯科大学病院（東京都）、山口大学病院（山口県）、大阪大学病院（大阪府）、名古屋大学病院（愛知県）、愛媛大学病院（愛媛県）、慶應義塾大学病院（東京都）、杏林大学病院（東京都）、金沢大学病院（石川県）、埼玉医科大学総合医療センター（埼玉県）、聖マリアンナ医科大学病院（神奈川県）、 順天堂大学病院（東京都）、香川大学病院（香川県）、北海道大学病院（北海道）、長崎大学病院（長崎県）、愛知医科大学病院（愛知県）、筑波大学病院（茨城県）、名古屋市立大学病院（愛知県）、島根大学病院（島根県）、秋田大学病院（秋田県）、大阪南医療センター（大阪府）、東京大学病院（東京都）、国立循環器病センター（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 03 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	Completed
Date of protocol fixation	2012 Year 11 Month 02 Day
Date of IRB	2012 Year 11 Month 27 Day
Anticipated trial start date	2012 Year 11 Month 28 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 07 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information	Prospective observational study

Management information
Registered date	2013 Year 04 Month 03 Day
Last modified on	2019 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012182