anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease
Conditions
Interventions
Patients without poor prognostic factors: combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of p
Sponsors
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with DM/CADM-ILD who are positive for serum anti-MDA5 antibodies and have not previously received treatment for DM/CADM-ILD.
Exclusion criteria
Exclusion criteria: Patients who meet the following criteria are excluded from this study: (1) Patients who require systemic high dose corticosteroid, immunosuppressants, intravenous immunoglobulin therapy, plasma exchange, or biologic agents for a disease other than DM/CADM-ILD at the registration (2) Patients with contraindication of prednisolone or tacrolimus (3) Patients with a serious comorbidity (e.g. advanced malignancy, imminent aortic aneurysm, and Liver cirrhosis) (4) Patients who are judged unqualified for this study by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival and progression free survival rate at 12 month in patients with anti-MDA5 antibody-positive DM/CADM-ILD without poor prognostic factors | — |
Secondary
| Measure | Time frame |
|---|---|
| "The patients without poor prognostic factor" Overall survival and overall survival rate at 12 month Change in FVC, FEV1, DLCO, PaO2, SPO2, KL-6, SP-D, anti-MDA5 antibody titer, Chest HRCT findings Incidence of adverse events "The patients with poor prognostic factor" Overall survival and overall survival rate at 12 month. | — |
Countries
Japan
Contacts
Public ContactTomoyuki Fujisawa
Hamamatsu University School of Medicine Second Division, Department of Internal Medicine
Outcome results
None listed