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Comprehensive immunogenetic characterization of juvenile dermatomyositis using a large-scale functional genomics database

Comprehensive immunogenetic characterization of juvenile dermatomyositis using a large-scale functional genomics database - GUIDE-JDM

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061138
Enrollment
20
Registered
2026-04-03
Start date
2026-04-03
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

juvenile dermatomyositis

Interventions

None listed

Sponsors

Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Juvenile dermatomyositis (JDM) patients] Participants must meet all of the following criteria: 1. Age >= 3 years at the time of consent 2. Newly diagnosed cases classified as definite or probable idiopathic inflammatory myopathy (IIM) according to the 2017 EULAR/ACR classification criteria, and meeting all of the following conditions: a) Age at disease onset < 18 years b) Presence of heliotrope rash, Gottron's papules, or Gottron's sign (not required in anti-NXP2 antibody positive cases) c) Score thresholds: >= 7.5 (definite) or >= 5.5 (probable) without muscle biopsy, and >= 8.7 (definite) or >= 6.7 (probable) with muscle biopsy In addition, the Japanese diagnostic guideline for the Specified Chronic Pediatric Diseases Program is also reviewed as a reference 3. No prior treatment with the following: a) Systemic glucocorticoids b) Immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine) c) Targeted therapies (e.g., rituximab, abatacept, belimumab, anifrolumab, tocilizumab, anti-TNF agents, JAK inhibitors) 4. Written informed consent obtained from a parent or legal guardian [Controls] Participants must meet all of the following criteria: 1. Age >= 3 years at the time of consent 2. No history of immune mediated or chronic inflammatory diseases and not receiving long term immunosuppressive therapy (e.g., patients with food allergy) 3. Written informed consent obtained from a parent or legal guardian

Exclusion criteria

Exclusion criteria: Individuals deemed inappropriate for participation in this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Cell type-specific gene expression profiles and expression quantitative trait loci (eQTL) effects in peripheral blood mononuclear cells in patients with juvenile dermatomyositis (JDM) before treatment initiation and at 1 year after treatment initiation

Secondary

MeasureTime frame
1. Identification of immunological and immunogenetic characteristics associated with differences in myositis-specific autoantibodies (MSAs) 2. Identification of immunological and immunogenetic characteristics associated with differences in clinical features (e.g., disease activity and organ involvement) 3. Identification of JDM-specific immunological and immunogenetic characteristics through comparison with adult-onset dermatomyositis

Countries

Japan

Contacts

Public ContactYuzaburo Inoue

Chiba University Graduate School of Medicine, Department of General Medical Science

yuzaburo@chiba-u.jp043-226-2823

Outcome results

None listed

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