UMIN-CTR Clinical Trial

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
Institute	Nagoya City University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040741