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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

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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
Japan

Condition
Condition Anti-neutrophil cytoplasmic antibody(ANCA) associated vasculitis
Classification by specialty
Medicine in general Pneumology Nephrology
Clinical immunology Dermatology Oto-rhino-laryngology
Radiology Laboratory medicine
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with newly diagnosed ANCA related vasculitis
No previous treatments
Key exclusion criteria Patients with relapse
Malignancy
Replicating hepatitis B and C
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Makino
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
Email makino@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken-ei Sada
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
Email 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
Email

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
2009 Year 02 Month 28 Day

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
2009 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 01 Month 25 Day

Other
Other related information Multivariate analysis is used to examine the relationship between induction therapy and the endpoint.

Management information
Registered date
2009 Year 01 Month 20 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001956


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