Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/21/2018
Start Date:February 21, 2015
End Date:June 12, 2017

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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

Inclusion Criteria:

- Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR
20110 criteria >/= 6 months at the time of baseline visit

- Patient must have active disease defined as DAS28-CRP>/=3.2

- Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR)
>/=28mm/h

- Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after
proper dose escalation according to local standards

Exclusion Criteria:

- Previous exposure to etanercept in the past

- Patients with functional status class IV according to the ACR 1991 revised criteria

- History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by
imaging and/or by the QuantiFERON-TB Gold test at screening
We found this trial at
25
sites
Austin, Texas 78759
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Carrollton, Texas 75010
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Clearwater, Florida 33756
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Clearwater, FL
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El Cajon, California 92020
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El Cajon, CA
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Frederick, Maryland 21702
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Gainesville, Florida 32608
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Gainesville, FL
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Lexington, Kentucky 40509
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Lexington, KY
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Miami, Florida 33136
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Monroe, Louisiana 71203
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Monroe, LA
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Orchard Park, New York 14127
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Orlando, Florida 32806
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Peoria, Arizona 85381
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Phoenix, Arizona 85012
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Plovdiv,
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Rapid City, South Dakota 57701
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Saint Louis, Missouri 63128
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Spokane, Washington 99202
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Tampa, Florida 33613
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Tampa, FL
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Trumbull, Connecticut 06611
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Upland, California 91786
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Upland, CA
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Van Nuys, California 91405
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Zephyrhills, Florida 33542
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