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A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

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A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Annals of the Rheumatic Diseases
Volume 76, Issue 3

Dae Hyun YooChang-Hee SuhSeung Cheol ShimSlawomir JekaFrancisco Fidencio Cons-MolinaPawel HrycajPiotr WilandEun Young LeeFrancisco G Medina-RodriguezPavel ShesternyaSebastiao RadominskiMarina StanislavVolodymyr KovalenkoDong Hyuk SheenLeysan MyasoutovaMie Jin Lim, Jung-Yoon ChoeSang Joon LeeSung Young LeeTaek Sang KwonWon Park.

Abstract

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.

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