1. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis
- Author
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Dong Hyuk Sheen, Piotr Wiland, Francisco Fidencio Cons-Molina, Pavel Shesternya, Chang Hee Suh, Paweł Hrycaj, Dae Hyun Yoo, Mie Jin Lim, Marina Stanislav, Taek Sang Kwon, Seung Cheol Shim, Won Park, Eun Young Lee, Volodymyr Kovalenko, Sebastião Cezar Radominski, Leysan Myasoutova, Sang Joon Lee, Sławomir Jeka, Sung Young Lee, Francisco G. Medina-Rodriguez, and Jung Yoon Choe
- Subjects
Adult ,Male ,medicine.medical_specialty ,Immunology ,Rheumatoid Arthritis ,DMARDs (biologic) ,Pharmacology ,Bioequivalence ,Severity of Illness Index ,Gastroenterology ,Antibodies ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Intolerances ,Pharmacokinetics ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,030203 arthritis & rheumatology ,B cells ,business.industry ,Middle Aged ,Clinical and Epidemiological Research ,medicine.disease ,Treatment ,Methotrexate ,Therapeutic Equivalency ,Antirheumatic Agents ,030220 oncology & carcinogenesis ,Pharmacodynamics ,Rheumatoid arthritis ,Drug Therapy, Combination ,Female ,Rituximab ,business ,medicine.drug - Abstract
ObjectiveTo 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.MethodsIn 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.Results103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC0–last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.ConclusionsCT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.Trial registration numberNCT01534884.
- Published
- 2016
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