A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy - Choe, Jung-Yoon; Prodanovic, Nenad; Niebrzydowski, Jaroslaw; Staykov, Ivan; Dokoupilova, Eva; Baranauskaite, Asta; Yatsyshyn, Roman; Mekic, Mevludin; Porawska, Wieskawa; Ciferska, Hana; Jedrychowicz-Rosiak, Krystyna; Zielinska, Agnieszka; et al. (Annals of the rheumatic diseases, 2017)
Keywords: Adult; Aged; Antibodies - blood; Antirheumatic Agents - adverse effects; Antirheumatic Agents - pharmacokinetics; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Biological products; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - therapeutic use; Clinical and Epidemiological Research; Double-Blind Method; Drug dosages; Family medical history; Female; Humans; Infliximab - adverse effects; Infliximab - immunology; Infliximab - pharmacokinetics; Infliximab - therapeutic use; Male; Methotrexate - therapeutic use; Middle Aged; Rheumatoid arthritis; Severity of Illness Index; Therapeutic Equivalency; Treatment Outcome; Tuberculosis; Tumor necrosis factor-TNF; Anti-TNF; DMARDs (biologic); Disease Activity; Rheumatoid Arthritis