Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid
arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic
therapies.
Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center
global study. The primary end point is 20% improvement in American College of Rheumatology
criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.
Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response
receive CHS-0214. Continued response and safety will be evaluated.