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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000017613 |
Receipt No. | R000020414 |
Scientific Title | Japanese prospective observational study on the current state and efficacy of diagnosis and therapeutics for large vessel vasculitis, -Takayasu's arteritis and Giant cell arteritis- |
Date of disclosure of the study information | 2015/05/18 |
Last modified on | 2019/05/22 |
Basic information | ||
Public title | Japanese prospective observational study on the current state and efficacy of diagnosis and therapeutics for large vessel vasculitis, -Takayasu's arteritis and Giant cell arteritis- | |
Acronym | Japanese prospective observational study on the current state and efficacy of diagnosis and therapeutics for large vessel vasculitis | |
Scientific Title | Japanese prospective observational study on the current state and efficacy of diagnosis and therapeutics for large vessel vasculitis, -Takayasu's arteritis and Giant cell arteritis- | |
Scientific Title:Acronym | Japanese prospective observational study on the current state and efficacy of diagnosis and therapeutics for large vessel vasculitis | |
Region |
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Condition | |||||
Condition | Large Vessel Vasculitis
(Takayasu's arteritis, Giant cell arteritis) |
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Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To clarify the current state and efficacy of diagnosis and 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 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 |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | ||||||
Division name | Chronic Kidney Disease and Cardiovascular Disease | ||||||
Zip code | 7008558 | ||||||
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama city | ||||||
TEL | 086-235-7235 | ||||||
hauchida@okayama-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | ||||||
Division name | Chronic Kidney Disease and Cardiovascular Disease | ||||||
Zip code | 7008558 | ||||||
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama city | ||||||
TEL | 086-235-7235 | ||||||
Homepage URL | |||||||
hauchida@okayama-u.ac.jp |
Sponsor | |
Institute | The Specified Disease Treatment Research Program
Mitsuaki Isobe |
Institute | |
Department |
Funding Source | |
Organization | The Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
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 | 086-235-6504 |
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 | 東京医科歯科大学病院(東京都)、岡山大学病院(岡山県)、川崎医科大学病院(岡山県)、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)、東京都健康長寿医療センター(東京都)
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)、新潟県立リウマチセンター(新潟県)、 公益財団法人田附興風会医学研究所北野病院(大阪府)、産業医科大学病院(福岡県)、黒部市民病院(富山県)、旭川医科大学病院(北海道)、帝京大学病院(東京都)、千葉大学病院(千葉県)、帝京大学ちば総合医療センター(千葉県)、東京女子医科大学附属リウマチ痛風センター(東京都)、横浜市立大学(神奈川県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 191 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020414 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |