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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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Peoria, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
El Cajon, California, United States
Novartis Investigative Site
Upland, California, United States
Novartis Investigative Site
Van Nuys, California, United States
Novartis Investigative Site
Trumbull, Connecticut, United States
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Start Date
February 21, 2015
Primary Completion Date
December 29, 2016
Completion Date
June 12, 2017
Last Updated
September 19, 2018
376
ACTUAL participants
GP2015
DRUG
Lead Sponsor
Sandoz
NCT06647069
NCT07484243
Data Source & Attribution
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