UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057829 |
|---|---|
| Receipt number | R000065998 |
| Scientific Title | Evaluation of the Diagnostic Utility of the MBDA Score and Related Biomarkers for Early Detection of Rheumatoid Arthritis in Patients with Undifferentiated Arthritis: A Comparison of AORA and EORA |
| Date of disclosure of the study information | 2025/05/11 |
| Last modified on | 2025/05/11 09:38:21 |
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Basic information
Public title
Evaluation of the Diagnostic Utility of the MBDA Score and Related Biomarkers for Early Detection of Rheumatoid Arthritis in Patients with Undifferentiated Arthritis: A Comparison of AORA and EORA
Acronym
MBDA and Biomarkers in Early RA Diagnosis (AORA/EORA)
Scientific Title
Evaluation of the Diagnostic Utility of the MBDA Score and Related Biomarkers for Early Detection of Rheumatoid Arthritis in Patients with Undifferentiated Arthritis: A Comparison of AORA and EORA
Scientific Title:Acronym
MBDA and Biomarkers in Early RA Diagnosis (AORA/EORA)
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Undifferentiated arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive utility of the MBDA score for RA development in patients with undifferentiated arthritis, stratified by age at onset (AORA and EORA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of baseline MBDA score in predicting RA diagnosis at 3-year follow-up
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with undifferentiated arthritis who presented with joint pain within 6 months of onset and visited a medical facility
Patients from whom residual serum samples obtained for clinical purposes at first visit were available and used for this study with written informed consent
Patients for whom ACPA, RF, and MBDA score could be measured
Key exclusion criteria
Patients from whom serum samples were not collected or not stored at the initial visit
Patients whose residual serum was insufficient for measuring ACPA, RF, or MBDA score
Patients who had received any treatment for rheumatoid arthritis (e.g., DMARDs, biologics, JAK inhibitors) or corticosteroids prior to or at the initial visit
Patients who did not provide written informed consent
Target sample size
167
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Hiura |
Organization
Hokkaido University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
006-5858
Address
7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido 006-8585, Japan
TEL
0116812126
hiura-k@hus.ac.jp
Public contact
Name of contact person
| 1st name | Kazuay |
| Middle name | |
| Last name | Hiura |
Organization
Hokkaido University of Science
Division name
Faculty of Pharmaceutical Sciences
Zip code
0068585
Address
7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido 006-8585, Japan
TEL
0116768574
Homepage URL
hiura-k@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Ethics Committee, Hokkaido Spinal Cord Injury Center
Address
1-3, Higashi 4jo Minami 1-chome, Bibai-shi, Hokkaido, Japan
Tel
0126-63-2151
hokkaidoh-s@m.johas.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
| 2025 | Year | 05 | 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
257
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 10 | 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
This study is an analytical investigation using serum samples that were originally collected for diagnostic purposes. Written informed consent (opt-in) for research use was obtained from all patients in advance. Although the collection of data and specimens has been completed, this registration is being performed prior to the analysis in order to ensure transparency of the research process.
Management information
Registered date
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065998
