UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046086 |
|---|---|
| Receipt number | R000052523 |
| Scientific Title | Establishment of the best practice for patients with elderly-onset rheumatoid arthritis |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/12/29 12:30:12 |
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Basic information
Public title
Late-onset Rheumatoid Arthritis Registry Study
Acronym
LORIS Study
Scientific Title
Establishment of the best practice for patients with elderly-onset rheumatoid arthritis
Scientific Title:Acronym
Late-onset RA Registry Study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Geriatrics | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to establish a registry of patients with late-onset RA, of which number is suspected to be increasing rapidly. Based on the evidence derived from the registry data, we will propose optimal treatment strategies for the late-onset RA patientsd.
Basic objectives2
Others
Basic objectives -Others
Contribute to the improvement of the quality of RA treatment and the extension of healthy life expectancy in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Factors related to survival and cause of death
2) Factors related to hospitalization (malignancy, infection, cardiovascular events, fracture and pneumonia)
3) Prevalence of requiring long-term care and their grade
4) Changes in QOL (EQ-5D-5L) and factors related to the decline in QOL
5) Changes in physical function (HAQ) and factors related to decline in physical function
Key secondary outcomes
1) Trends in frailty and sarcopenia
2) Changes in physical functions other than HAQ and factors related to the decline in physical functions
3) Changes in cognitive function and factors related to decline in cognitive function
4) Changes in disease activity
5) Changes in joint destruction
6) Changes in Patient-reported Outcome
7) Whether MTX is administered, the dose and interval, if not, reasons for dose increase, decrease, or discontinuation
8) Whether or not molecularly targeted drugs are administered, and reasons for prolonging the interval, reducing the dose, or discontinuing.
9) GCs administration or not, dose, and reasons for dose increase or decrease or discontinuation
10) Whether or not NSAIDs are administered
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are 65 years of age or older and have a confirmed diagnosis of RA based on the ACR Rheumatoid Arthritis Classification Criteria 1987 or ACR/EULAR Rheumatoid Arthritis Classification Criteria 2010. Patients provide written informed consent and are eligible 1) or 2).
1) Patients who have never been treated with anti-rheumatic drugs and started anti-rheumatic drug therapy for the first time during the registration period (January 2022 to December 2023).
2) Patients who have been treated with anti-rheumatic drugs and started MTX or molecular targeted drugs (for the first drug) time during the registration period.
Patients who have already started treatment with anti-rheumatic drugs at other medical institutions may be enrolled within 30 days of the start of treatment.
Key exclusion criteria
1) Patients who are unable to give consent to participate in the research
2) Patients who have already received treatment with any of the molecular targeted drugs covered by insurance for rheumatoid arthritis.
3) Patients with systemic autoimmune disease complications other than Sjogren's syndrome.
4) Other patients deemed inappropriate for inclusion by the investigators or others.
Target sample size
700
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
Center for Gerontology and Social Science
Zip code
474-8511
Address
7-430, Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-44-5651
masayok@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Yasuoka |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Gerontology and Social Science
Zip code
474-8511
Address
7-430, Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-44-5651
Homepage URL
https://www.ncgg.go.jp/ri/lab/cgss/LORA-registry/
yasuoka@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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-cho, Obu City, Aichi Prefecture, Japan
Tel
0562-44-5651
yaday@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
名古屋大学、京都大学、聖マリアンナ医科大学、国立病院機構相模原病院、新潟県立リウマチセンター、岡山大学、金沢医科大学、東京女子医科大学、京都府立医科大学附属病院、慶應義塾大学、広島大学病院、杏林大学、倉敷中央病院、倉敷スイートホスピタル、西能クリニック、手稲渓仁会病院、大阪公立大学、国立病院機構名古屋医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry Study
Management information
Registered date
| 2021 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052523
