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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT02638259

Run by

Sandoz

People needed

376

Starts

2015-02-21

Expected to finish

2017-06-12

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Zephyrhills, Florida, United States
• Novartis Investigative Site — Lexington, Kentucky, United States
• Novartis Investigative Site — Monroe, Louisiana, United States
• Novartis Investigative Site — Frederick, Maryland, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Orchard Park, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Rapid City, South Dakota, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Carrollton, Texas, United States
• Novartis Investigative Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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