UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062106 |
|---|---|
| Receipt number | R000064888 |
| Scientific Title | Establishment of novel cohort to define preclinical rheumatoid arthritis (TATEYAMA [Tracking Arthritis Through Early Yield And Monitoring in Advance] cohort study) |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/22 22:43:30 |
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Basic information
Public title
Establishment of novel cohort to define preclinical rheumatoid arthritis (TATEYAMA [Tracking Arthritis Through Early Yield And Monitoring in Advance] cohort study)
Acronym
Establishment of novel cohort to define preclinical rheumatoid arthritis (TATEYAMA [Tracking Arthritis Through Early Yield And Monitoring in Advance] cohort study)
Scientific Title
Establishment of novel cohort to define preclinical rheumatoid arthritis (TATEYAMA [Tracking Arthritis Through Early Yield And Monitoring in Advance] cohort study)
Scientific Title:Acronym
Establishment of novel cohort to define preclinical rheumatoid arthritis (TATEYAMA [Tracking Arthritis Through Early Yield And Monitoring in Advance] cohort study)
Region
| Japan |
Condition
Condition
preclinical and very early rheumatoid arthritis.
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characterise preclinical/very early rheumatoid arthritis.
Basic objectives2
Others
Basic objectives -Others
Exploring factors involved in the development of rheumatoid arthritis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The onset of rheumatoid arthritis(Annual follow-up for up to 3 years)
Key secondary outcomes
Swollen joint count, tender joint count, RF (rheumatoid factor), anti-CCP antibodies, CRP (C-reactive protein), ESR (erythrocyte sedimentation rate), ANA (antinuclear antibodies), MMP-3, KL-6, joint X-ray findings, joint ultrasound findings, joint MRI findings, chest X-ray findings, and the onset of rheumatic diseases or collagen diseases other than RA (rheumatoid arthritis)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult individuals who visited the clinic with joint pain as the chief complaint, or those who were found to be positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibodies during health checkups or medical screenings, but do not meet the ACR/EULAR classification criteria for RA (Aletaha D, et al. Ann Rheum Dis. 2010 Sep;69(9):1580-8).
Key exclusion criteria
Individuals who have been diagnosed with RA, rheumatic diseases, or collagen diseases and are currently undergoing or have previously undergone treatment.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kato |
Organization
University 0f Toyama
Division name
First Department of Internal Medicine, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama
TEL
076-434-7287
ktmasaru@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Asano |
Organization
University of Toyama
Division name
First Department of Internal Medicine, Faculty of Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7287
Homepage URL
aryoko@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital Clinical Research and Development Promotion Center
Address
2630 Sugitani, Toyama, Toyama, Japan
Tel
076-415-8857
rinri@adm.u-toyama.ac.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
| 2026 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational cohort study. Examinations and treatments will be performed within the scope of routine clinical practice at the discretion of the treating physician, and no study-specific intervention will be conducted. Clinical information, laboratory findings, imaging findings, and stored residual serum samples will be collected longitudinally from individuals at high risk of developing rheumatoid arthritis to evaluate their association with the development of rheumatoid arthritis.
Management information
Registered date
| 2026 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064888
