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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001648 |
Receipt No. | R000001956 |
Scientific Title | Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis |
Date of disclosure of the study information | 2009/02/28 |
Last modified on | 2017/01/25 |
Basic information | ||
Public title | Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis | |
Acronym | RemiT-JAV | |
Scientific Title | Observational cohort study of remission induction therapy in Japanese patients with ANCA-associated vasculitis | |
Scientific Title:Acronym | RemiT-JAV | |
Region |
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Condition | |||||||||
Condition | Anti-neutrophil cytoplasmic antibody(ANCA) associated vasculitis | ||||||||
Classification by specialty |
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Classification by malignancy | Others | ||||||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To know the efficacy and safety of remission induction therapy for ANCA-associated vasculitis in Japan.
To compare the Watts' algorithm and the Japanese criteria for the classification of ANCA-associated vasculitides. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Time to remission |
Key secondary outcomes | Survival
Cause of death Treatment response Relapse Severe infections and risk factor Other adverse events Pathologic analysis in pulmonary limited vasculitis The concordance rates of classification |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with newly diagnosed ANCA related vasculitis
No previous treatments |
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Key exclusion criteria | Patients with relapse
Malignancy Replicating hepatitis B and C |
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Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | ||||||
Division name | The Department of Medicine and Clinical Science | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Okayama-city, Okayama, 700-8558, Japan | ||||||
TEL | 086-235-7235 | ||||||
makino@md.okayama-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of | ||||||
Division name | Secretariat | ||||||
Zip code | |||||||
Address | 2-5-1 Shikata-cho, Okayama-city, Okayama, 700-8558, Japan | ||||||
TEL | 086-235-7235 | ||||||
Homepage URL | |||||||
vas-mhlw@md.okayama-u.ac.jp |
Sponsor | |
Institute | Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | The Ministry of Health, Labor and Welfare of Japan |
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 | |
Address | |
Tel | |
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(岡山県)、杏林大学 (東京都)、東京医科歯科大学 (東京都) 、香川大学 (香川県)、順天堂大学 (東京都)、聖マリアンナ医科大学 (神奈川県)、埼玉医大総合医療センター (埼玉県)、筑波大学膠原病内科 (茨城県)、京都大学 (京都府)、宮崎大学 (宮崎県)、東邦大学大森病院(東京都)、金沢大学 (石川県)、田附興風会北野病院(大阪府)、神戸大学 (兵庫県)、東京大学 (東京都)、島根大学 (島根県)、名古屋市立大学(愛知県)、愛媛大学(愛媛県)、自治医科大学(栃木県)、筑波大学腎臓内科(茨城県)、京都府立医科大学 (京都府)、東京医科大学八王子医療センター(東京都)、北里大学医学部 (神奈川県)、浜松医科大学(静岡県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://arthritis-research.com/content/16/2/R101 |
Number of participants that the trial has enrolled | |
Results | MPO-ANCA-positive MPA/RLV is the most common form of AAV in Japanese patients, and one-half of patients with GPA were positive for MPO-ANCA. ILD is an important clinical manifestation in Japanese patients with AAV. Unclassifiable vasculitis with MPO-ANCA positivity and ILD may represent a novel variant of MPA. |
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 |
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Date of IRB | |||||||
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information | Multivariate analysis is used to examine the relationship between induction therapy and the endpoint. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001956 |