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 |
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).
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
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
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