UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045119 |
|---|---|
| Receipt number | R000051539 |
| Scientific Title | Survey on Frailty and Sarcopenia in Rheumatoid Arthritis Patients |
| Date of disclosure of the study information | 2021/08/11 |
| Last modified on | 2022/08/17 10:22:32 |
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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
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
masayok@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051539
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
