UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001785
Receipt number R000002151
Scientific Title Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis
Date of disclosure of the study information 2009/03/31
Last modified on 2011/03/19 16:15:12

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Basic information

Public title

Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis

Acronym

Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis

Scientific Title

Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis

Scientific Title:Acronym

Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis

Region

Japan


Condition

Condition

Microscopic polyangiitis

Classification by specialty

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

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify risk factors of relapse during remission maintenance therapy in patients with MPO-ANCA-positive microscopic polyangiitis.

Basic objectives2

Others

Basic objectives -Others

Relapse rate

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Time to relapse

Key secondary outcomes

Risk factors of relapse
Change in vasculitis damage index


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 newly diagnosed microscopic polyangiitis between Jan.1, 2005 and Dec.31, 2006 and under the remission by initial remission induction therapy

Key exclusion criteria

Patients under 20 years old
Malignancy
Replicating hepatitis B and C
History of treatment with steroid and/or immunosuppressive drugs by initial therapy

Target sample size

100


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, 700-8558, Japan

TEL

086-235-7235

Email



Public contact

Name of contact person

1st name
Middle name
Last name

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

2009 Year 03 Month 31 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

2009 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2010 Year 01 Month 01 Day

Date of closure to data entry

2010 Year 04 Month 01 Day

Date trial data considered complete

2010 Year 10 Month 01 Day

Date analysis concluded

2011 Year 03 Month 01 Day


Other

Other related information

To clarify the rate of relapse and its risk factors during remission maintenance therapy in patients with MPO-ANCA-positive microscopic polyangiitis.


Management information

Registered date

2009 Year 03 Month 19 Day

Last modified on

2011 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002151


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name