A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.
Inclusion Criteria:
Exclusion Criteria:
Ciudad Autónoma Buenos Aires, Buenos Aires C1181ACH, Argentina
Brescia, 25123, Italy
Yoshida-Gun, Fukui 910-1193, Japan
Bunkyo, Tokyo 113-8519, Japan
Bunkyō-Ku, Tokyo 113-8603, Japan
Shinjuku-Ku, Tokyo 162-8666, Japan
Mexico City, Mexico City 11850, Mexico
San Luis Potosí City, 78213, Mexico
Zaporizhia, 69005, Ukraine