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Significance of myositis-specific autoantibodies (MSA) for clinical features in polymyositis/dermatomyositis-associated interstitial lung disease

Significance of myositis-specific autoantibodies (MSA) for clinical features in polymyositis/dermatomyositis-associated interstitial lung disease - MSA in PM/DM-ILD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000022605
Enrollment
100
Registered
2016-06-04
Start date
2014-04-01
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

Polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease

Interventions

None listed

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The diagnosis of PM or DM was based on the criteria of Bohan and Peter criteria: 1) systemic muscle weakness, 2) increased serum muscle enzyme levels, 3) electromyographic (EMG) evidence of myopathic changes, 4) typical histologic findings in muscle biopsies, and/or 5) characteristic dermatologic manifestations of DM. The diagnosis was considered definite, probable, or possible according to the number of criteria fulfilled (at least 4, 3, or 2, respectively, including the dermatologic manifestations for diagnosis of DM), and patients with definite or probable PM/DM were included in the study. CADM was diagnosed when a patient had a skin rash characteristic of DM without clinical evidence of muscle disease and with little or no increase in the serum creatine kinase (CK) level. Interstitial lung disease was diagnosed on the basis of the presence of high resolution computed tomography abnormalities in combination with one or more of the following; dyspnea on exertion, serum KL-6 level > 500 U/ml, arterial oxygen tension (PaO2) < 80mmHg, %FVC < 80%, %DLCO < 65%.

Exclusion criteria

Exclusion criteria: Patients who are unable to get informed consent

Design outcomes

Primary

MeasureTime frame
Clinical feature and overall survival according to MSA status

Secondary

MeasureTime frame
Prevalence of each myositis-specific autoantibodies Change of clinical symptoms, pulmonary function tests, chest HRCT findings, and laboratory findings during follow up period (3 years) Comparison of therapeutic regimen

Countries

Japan

Contacts

Public ContactTomoyuki Fujisawa

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

fujisawa@hama-med.ac.jp053-435-2263

Outcome results

None listed

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