Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062436) titled 'Clinical implications of myositis autoantibody levels in people living with myositis' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - International Myositis Assessment and Clinical Studies Group (IMACS)
Condition:
Condition - Idiopathic inflammatory myopathies
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the association of myositis-specific autoantibody (MSA) levels, as measured by enzyme-linked immunosorbent assay (ELISA), with myositis disease activity measures in patients with idiopathic inflammatoory myopathies (IIMs).
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Individuals who meet the following criteria are eligible for the study:
1. Individuals who meet any of the following classification criteria for IIM:
1.1. 2017 European Alliance and Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for IIM
1.2. 224th European Neuromuscular Centre (ENMC) Workshop classification criteria for immune-mediated necrotizing myopathy
1.3. Connors' criteria for anti-synthetase syndrome
2. Individuals who are positive for any of the following MSAs by autoantibody testing at each participating centre
2.1. Anti-Jo-1 autoantibody
2.2. Anti-MDA5 autoantibody
2.3. Anti-Mi-2 autoantibody
2.4. Anti-NXP2 autoantibody
2.5. Anti-SAE autoantibody
2.6. Anti-TIF1-gamma autoantibody
2.7. Anti-SRP autoantibody
2.8. Anti-HMGCR autoantibody
Key exclusion criteria - Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target Size - 1150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Date of IRB - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2025 Year 11 Month 27 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071454
Disclaimer: Curated by HT Syndication.
