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

• Status: Completed
• Trial end date: 2017-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Etanercept; GP2015

Criteria

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