Annals of the Rheumatic Diseases
Volume 76, Issue 3
Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Slawomir Jeka, Francisco Fidencio Cons-Molina, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Francisco G Medina-Rodriguez, Pavel Shesternya, Sebastiao Radominski, Marina Stanislav, Volodymyr Kovalenko, Dong Hyuk Sheen, Leysan Myasoutova, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Taek Sang Kwon, Won Park.
Objective To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.
Methods In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC0–last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.