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
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
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
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
