UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006373
Receipt number R000007563
Scientific Title Observational Cohort Study of Remission Maintenance Therapy in Japanese Patients with ANCA-associated Vasculitis
Date of disclosure of the study information 2011/09/21
Last modified on 2015/09/20 09:16:27

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Basic information

Public title

Observational Cohort Study of Remission Maintenance Therapy in
Japanese Patients with ANCA-associated Vasculitis

Acronym

Co-RemiT-JAV

Scientific Title

Observational Cohort Study of Remission Maintenance Therapy in
Japanese Patients with ANCA-associated Vasculitis

Scientific Title:Acronym

Co-RemiT-JAV

Region

Japan


Condition

Condition

ANCA-associated vasculitis

Classification by specialty

Medicine in general Gastroenterology Pneumology
Nephrology Neurology Clinical immunology
Dermatology Oto-rhino-laryngology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the safety and efficacy of remission maintenance therapy in Japanese patients with ANCA-associated vasculitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relapse rate
Renal and patients' survival

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ANCA-associated vasculitis registered in RemIT-JAV study and under the remission maintenancy therapy

Key exclusion criteria

Patients without the agreement

Target sample size

150


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 Sciences

Division name

The Department of Medicine and Clinical Science

Zip code


Address

2-5-1 Shikata-cho, Okayama-city, Okayama, Japan

TEL

086-235-7235

Email

vas-mhlw@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 or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Health, Labor and Welfare of Japan

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Completed

Date of protocol fixation

2011 Year 09 Month 21 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Medical data on each patient are collected to clarify the safety and efficacy of remission maintenance therapy in Japanese patients with ANCA-associated vasculitis.


Management information

Registered date

2011 Year 09 Month 20 Day

Last modified on

2015 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name