UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047764 |
|---|---|
| Receipt number | R000054455 |
| Scientific Title | Construction of an algorithm for predicting the progression of rheumatoid arthritis (RA) and elucidation of the onset mechanism of RA by utilization of multidimensional evaluation |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/12/16 14:52:28 |
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Basic information
Public title
Construction of an algorithm for predicting the progression of rheumatoid arthritis (RA) and elucidation of the onset mechanism of RA by utilization of multidimensional evaluation
Acronym
Construction of an algorithm for predicting the progression of rheumatoid arthritis (RA) and elucidation of the onset mechanism of RA by utilization of multidimensional evaluation
Scientific Title
Construction of an algorithm for predicting the progression of rheumatoid arthritis (RA) and elucidation of the onset mechanism of RA by utilization of multidimensional evaluation
Scientific Title:Acronym
Construction of an algorithm for predicting the progression of rheumatoid arthritis (RA) and elucidation of the onset mechanism of RA by utilization of multidimensional evaluation
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To create an algorithm "RA progress prediction algorithm" that accurately predicts the risk of progress to RA in "patients with arthralgia".
Basic objectives2
Others
Basic objectives -Others
To elucidate RA onset mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RA diagnosis within 12 months from the first visit
Key secondary outcomes
Associations between RA diagnosis and HLA-DRB1 SE, serum biomarkers, AMPAs, salivary microbiota composition, ultrasound (hand) / MRI (hand) abnormal findings
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with undiagnosed arthralgia in the hands less than 12 months after the onset of symptoms and patients without anti-rheumatic drug introduction
2. (A) New patients: Among the patients who first visited the outpatient department of Nagasaki University Hospital between the date of permission of the director of the research institute and March 31, 2024, those who obtained the consent for a dental examination, or (B) Existing patients: 2010 Among the patients who first visited the outpatient department of Nagasaki University Hospital between January 1 and the research permission date, those who are currently in the hospital with preserved serum and preserved images of X-ray (hand/foot) / ultrasound (hand) or MRI (hand) within 2 months from the time of the first visit.
Key exclusion criteria
1. Patients receiving anti-rheumatic drugs at the first visit and at the time of serum storage/imaging evaluation
2. Patients without residual teeth
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
N/A
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7262
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin-ya |
| Middle name | |
| Last name | Kawashiri |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
N/A
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7262
Homepage URL
shin-ya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan College of Rheumatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7726
shin-ya@nagasaki-u.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
| 2022 | Year | 06 | 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
| 2022 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054455
