UMIN-CTR Clinical Trial

Basic information
Public title	Survey on Frailty and Sarcopenia in Rheumatoid Arthritis Patients
Acronym	Survey on Frailty and Sarcopenia in Rheumatoid Arthritis Patients
Scientific Title	Survey on Frailty and Sarcopenia in Rheumatoid Arthritis Patients
Scientific Title:Acronym	Survey on Frailty and Sarcopenia in Rheumatoid Arthritis Patients
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the interrelationships between physical and psychosocial factors and frailty
Basic objectives2	Others
Basic objectives -Others	To assess the relationship physical and psychosocial factors and frailty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frailty and sarcopenia
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with rheumatoid arthritis who meet the 1987 criteria of ACR or the 2010 criteria of the ACR/EULAR and under the management of board certified rheumatologists. Additionally, patients are undergoing treatment and follow-up and meet all of the following conditions 1) Age 50 years or older at the date of consent 2) Written consent has been obtained from the subject himself/herself for participation in this study 3) Able to answer and fill in the self-administered survey form by themselves. 4) Patients who are receiving molecular targeted drugs, csDMARDs or GCs at the start of the study
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masayo Middle name Last name Kojima
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Frailty Research
Zip code	474-8511
Address	7-430 Morioka, Obu, Aichi
TEL	0562-46-2311
Email	masayok@ncgg.go.jp

Public contact
Name of contact person	1st name Masayo Middle name Last name Kojima
Organization	National Center for Geriatrics and Gerontology
Division name	masayok@ncgg.go.jp
Zip code	474-8511
Address	7-430 Morioka, Obu, Aichi
TEL	0562-46-2311
Homepage URL
Email	masayok@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430 Morioka, Obu, Aichi
Tel	0562-46-2311
Email	masayok@ncgg.go.jp

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	2021 Year 08 Month 11 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	64
Results	We obtained written informed consent from 64 RA patients. At baseline survey, 58 RA participants answered the questionnaire and were checked physical examination. We did same examination for 53 participants one year later.
Results date posted	2022 Year 08 Month 17 Day
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 06 Day
Date of IRB	2020 Year 10 Month 06 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	following up now

Management information
Registered date	2021 Year 08 Month 11 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051539