UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010414
Receipt number R000012182
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-
Date of disclosure of the study information 2013/04/03
Last modified on 2019/04/08 09:48:53

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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

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

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 or person

Institute

The Specified Disease Treatment Research Program

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012182


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name