Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial
Not Applicable
Recruiting
- Conditions
- anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease
- Registration Number
- JPRN-UMIN000032022
- Lead Sponsor
- Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who meet the following criteria are excluded from this study: (1) Patients who requires systemic high dose corticosteroid, immunosuppressants, intravenous immunoglobulin therapy, plasma exchange, or biologic agents for a disease other than PM/DM/CADM-ILD at the registration (2) Patients with severe respiratory failure (PaO2 < 50 Torr) (3) Patients with contraindication of prednisolone or tacrolimus (4) Patients with a serious comorbidity (e.g. advanced malignancy, imminent aortic aneurysm, and Liver cirrhosis) (5) Patients with anti-MDA5 antibody (6) Patients who are judged unqualified for this study by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival and progression free survival rate at 12 and 24 month
- Secondary Outcome Measures
Name Time Method Disease control rate at 1 month Recurrence free survival and recurrence free survival rate at 12 and 24 month Incidence of adverse events Overall survival and overall survival rate at 12 and 24 month Non-elective hospitalization rate (all-cause, PM/DM/CADM-ILD related, and non-PM/DM/CADM-ILD related) Change in PM/DM/CADM-ILD related symptom, FVC, FEV1, KL-6, SP-D, anti-aminoacyl-tRNA synthetase antibody titer, Chest HRCT findings)