UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038053
Receipt number R000040741
Scientific Title Epidemiological QOL study of patients with rheumatoid arthritis
Date of disclosure of the study information 2019/09/19
Last modified on 2022/09/19 10:52:05

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Basic information

Public title

Epidemiological QOL study of patients with rheumatoid arthritis

Acronym

RA epidemiological QOL study

Scientific Title

Epidemiological QOL study of patients with rheumatoid arthritis

Scientific Title:Acronym

RA epidemiological QOL study

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the epidemiological characteristics of rheumatoid arthritis focusing on health-related QOL.

Basic objectives2

Others

Basic objectives -Others

We will follow the patients for two year and identify the risk factor of care dependency.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Care dependency

Key secondary outcomes

Activities on daily living


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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with rheumatoid arthritis who meet the 2010 criteria of the ACR/EULAR and under the management of board cerified rheumatologists .

Key exclusion criteria

Age <40 or >=80 year old.

Those who do not offer written informed consents.

Those who cannot complete the self-administarative questionnaire by themselves.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Masayo
Middle name
Last name Kojima

Organization

Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology

Division name

Department of Frailty Research

Zip code

4668601

Address

7-430Morioka, Obu, Aichi

TEL

0562-46-2311

Email

masayok@ncgg.go.jp


Public contact

Name of contact person

1st name Sadao
Middle name
Last name Suzuki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Public Health

Zip code

4668601

Address

Kawasumi1, Mizuho, Nagoya

TEL

0528538176

Homepage URL


Email

masayok@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

Japanese Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya University
National Center for Geriatrics and Gerontology

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya City University Graduate School of Medical Sciences

Address

Kawasumi1, Mizuho, Nagoya

Tel

052-853-7215

Email

irb_jimu@med.nagoya-cu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

60-18-0171

Org. issuing International ID_1

Nagoya City University Graduate School of Medical Sciences

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

名古屋市立大学病院(愛知県)
名古屋大学医学部付属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 19 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

Main results already published

Date of protocol fixation

2018 Year 12 Month 21 Day

Date of IRB

2018 Year 12 Month 27 Day

Anticipated trial start date

2019 Year 02 Month 12 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients who meet the research criteria are invited to participate in the baseline survey by rheumatologists when they visit the outpatient rheumatology clinics. Self-administrative questionnaire is handed by rheumatologists to the patients who give written informed consents. The patients complete the questionnaires and return them by mail. Number of swelling and/or tender joints, CRP value and clinical history are recorded. Combine clinical and questionnaire data will be analyzed to detect epidemiological characteristics of each generation. After 2 years, we conduct a follow-up survey by mailing method and estimate the risk factor of care dependency.


Management information

Registered date

2019 Year 09 Month 19 Day

Last modified on

2022 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name