Conditions: Rheumatoid Arthritis
Keywords: CHS-0214 Enbrel RA Biosimilar Etanercept
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 647
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Enbrel 50mg weekly times 24 weeks. arm 2: CHS-0214 50mg weekly times 24 weeks.

Interventions: intervention 1: Etanercept intervention 2: CHS-0214
Intervention descriptions: intervention 1: Head-to-head comparison intervention 2: None

Protocol document: