UMIN-CTR Clinical Trial

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
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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001956

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