Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial.

ABSTRACT: This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC_0-last), AUC from time zero to infinity (AUC_0-∞), and maximum concentration (C_max) after two infusions. The primary efficacy endpoint was change from baseline to week 24 in Disease Activity Score u

SUBMITTER: Park W 

PROVIDER: S-EPMC6152436 | biostudies-literature | 2018 Aug/Sep

REPOSITORIES: biostudies-literature