Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study - Schiopu, Elena; Chatterjee, Soumya; Hsu, Vivien; Flor, Armando; Cimbora, Daniel; Patra, Kaushik; Yao, Wenliang; Li, Jing; Streicher, Katie; McKeever, Kathleen; White, Barbara; Katz, Eliezer; et al. (Arthritis research & therapy, 2016)
Keywords: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - pharmacokinetics; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - pharmacokinetics; Antigens, CD19; Area Under Curve; Arthritis; B cells; Dosage and administration; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Enzyme-Linked Immunosorbent Assay; Female; Flow Cytometry; Health aspects; Humans; Male; Middle Aged; Monoclonal antibodies; ROC Curve; Scleroderma (Disease); Scleroderma, Systemic - drug therapy; Sclerosis; Systemic scleroderma; United States; Pharmacodynamics; B cells; Pharmacokinetics; Scleroderma; CD19; Systemic sclerosis