A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
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.
Inclusion Criteria:
Exclusion Criteria:
Takasaki-shi, Gunma 370-0053, Japan
Omura-shi, Nagasaki 856-0836, Japan
Ehime, 790-0905, Japan
Morioka Iwate, 020-0034, Japan
Kodz, 90242, Poland
Moscow, 111539, Russia
Saint Petersburg, 198260, Russia
Yaroslavl, 150003, Russia
Merseyside, CH495PE, United Kingdom