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Clinical Trials/JPRN-UMIN000032022
JPRN-UMIN000032022
Recruiting
未知

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 - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD

Hamamatsu University School of Medicine0 sites66 target enrollmentApril 1, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease
Sponsor
Hamamatsu University School of Medicine
Enrollment
66
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2018
End Date
March 31, 2028
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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