A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis
ADULT;
AGED;
AREA UNDER THE CURVE;
ARTICLE;
B LYMPHOCYTE;
BIOEQUIVALENCE;
CONTROLLED STUDY;
DAS28;
DOUBLE BLIND PROCEDURE;
DRUG CLEARANCE;
DRUG EFFICACY;
DRUG RESPONSE;
DRUG SAFETY;
ELIMINATION HALF-LIFE;
FEMALE;
HEADACHE;
HUMAN;
IMMUNOGENICITY;
INFECTION;
INFUSION RELATED REACTION;
MAJOR CLINICAL STUDY;
MALE;
MAXIMUM PLASMA CONCENTRATION;
MINIMUM PLASMA CONCENTRATION;
MULTICENTER STUDY;
PHASE 1 CLINICAL TRIAL;
PLASMA CONCENTRATION-TIME CURVE;
RANDOMIZED CONTROLLED TRIAL;
RHEUMATOID ARTHRITIS;
TIME TO MAXIMUM PLASMA CONCENTRATION;
VOLUME OF DISTRIBUTION;
ARTHRITIS, RHEUMATOID;
BLOOD;
CLINICAL TRIAL;
COMBINATION DRUG THERAPY;
COMPARATIVE STUDY;
IMMUNOLOGY;
MIDDLE AGED;
SEVERITY OF ILLNESS INDEX;
THERAPEUTIC EQUIVALENCE;
B cells in rheumatoid arthritis: From pathogenic players to disease biomarkers
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Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks
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The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial
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Committee for Medicinal Products for Human Use (CHMP)
(accessed 11 Feb, 2016) December. European Medicines Agency
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Population pharmacokinetics of rituximab (anti-CD20 monoclonal antibody) in rheumatoid arthritis patients during a phase II clinical trial
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Rituximab pharmacokinetics in patients with rheumatoid arthritis: B-cell levels do not correlate with clinical response
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Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)
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False-positive immunogenicity responses are caused by CD20+ B cell membrane fragments in an anti-ofatumumab antibody bridging assay
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