Rheumatoid Arthritis Clinical Trial
Official title:
A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy
This is a multicentre, randomised, double-blind, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance or documented active disease despite at least 12 weeks treatment according to the TNF inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.
This study will take place across approximately 31 centres across 12 countries and will
randomise approximately 150 subjects as outpatients.
The primary objective is to investigate and compare the pharmacokinetic profiles of JHL1101
and MabThera (rituximab). The secondary objectives are to investigate the safety,
tolerability, and immunogenicity of JHL1101 versus MabThera, to investigate the
pharmacodynamics profile of JHL1101 versus MabThera, and investigate the efficacy of JHL1101
versus MabThera.
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