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Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis

Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis - Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049776
Enrollment
150
Registered
2022-12-14
Start date
2022-11-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-MDA5 antibody-positive dermatomyositis

Interventions

Blood sampling for healthy controls

Sponsors

Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Anti-MDA5 antibody-positive dermatomyositis group: 1) Patients diagnosed with dermatomyositis who fulfill the criteria of Bohan and Peter, or clinically amyopathic dermatomyositis who fulfill the criteria of Sontheimer. 2) Patients with positive anti-MDA5 antibody. Connective tissue disease group: Patients who fulfill either of the following criteria. - 1997 American College of Rheumatology (ACR) Criteria of systemic lupus erythematosus - ACR/European Alliance of Associations for Rheumatology (EULAR) 2010 rheumatoid arthritis classification criteria - 2012 Revised international Chapel Hill Consensus Conference nomenclature of vasculitis - ACR/EULAR 2013 Classification Criteria for Systemic Sclerosis - American-European Consensus Criteria for Sjogren's Syndrome (2002) Healthy control group: People who do not fulfill any of the criteria of anti-MDA5 antibody-positive dermatomyositis or connective tissue disease. Of any of the above groups, those participants who fulfill the following 1) and 2) will be included in this study. 1) The person who fully understands this study and gives his/her consent or that of his/her legal representative. 2) 18 years or older when serum was taken.

Exclusion criteria

Exclusion criteria: 1) Patients or health controls who cannot give consent. 2) Patients or health controls who are unable to collect specimens. 3) Patients or health controls who are eligible to opt-out and who have requested to opt-out 4) Patients or health controls with other diseases or conditions that are considered inappropriate for this study. 5) Healthy controls with a history of connective tissue disease.

Design outcomes

Primary

MeasureTime frame
We will conduct an analysis of the correlation between serum interferon activity and clinical manifestations, hematological findings, severity of interstitial lung disease (ILD), and outcomes in MDA5-DM patients. Additionally, using various clinical indicators, we will perform latent cluster analysis to establish a novel disease classification by examining the association between disease subtypes and serum interferon levels. The measurement of interferon will be performed using the WISH IFN bioassay (Genes Immun 2007;8:492), which allows for the detection of serum interferon activity at approximately 100 times the sensitivity of conventional ELISA. Furthermore, we will use the ultra-sensitive digital ELISA method for interferon detection.

Countries

Japan

Contacts

Public ContactTomoaki Ida

Chiba University Graduate School of Medicine Department of Allergy and Clinical Immunology

t.ida@chiba-u.jp043-226-2198

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026