UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan

Institute

Department

Personal name

Organization

The Ministry of Health, Labor and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2009

Year

02

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related information

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

Registered date

2009

Year

01

Month

20

Day

Last modified on

2017

Year

01

Month

25

Day

Link to view the page

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