Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate
to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic
drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both
products, including immunogenicity and local tolerability at the injection sites, will be
collected and compared.
An additional study objective is to identify any potential risk of the transition from Enbrel
to GP2015 in terms of general safety and immunogenicity in RA patients
;
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