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Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease

Not Applicable
Conditions
polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease
Registration Number
JPRN-UMIN000015469
Lead Sponsor
Second Division, Department of Internal medicine, Hamamatsu University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

Patients who met the following criteria are excluded from this study: (i) no evidence of deterioration in interstitial lung disease for more than 6 months; (ii) the presence of a serious comorbidity (e.g. malignancy, liver dysfunction, and renal dysfunction); (iii) use of immunosuppressants (except for corticosteroid), intravenous immunoglobulin therapy, plasma exchange.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival rate at week 52
Secondary Outcome Measures
NameTimeMethod
Overall survival rate at week 52 Change in forced vital capacity from baseline at week 52. Change in DLCO, 6MWT,PaO2, KL-6 and SP-D from baseline at week 4, 12, 24 and 52.
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