Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Coherus Biosciences, Inc.
• Collaborator: Daiichi Sankyo Co., Ltd.
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Male or female adults

• RA (Rheumatoid Arthritis) diagnosis for 6 months

• On stable dose of MTX of 8mg to 25mg per week

• Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2

Exclusion Criteria:

• Use of prednisone greater than 10mg/day

• Use of greater than one non-steroidal anti-inflammatory drug (NSAID)

• Use of biologic therapies for any cause

• Chemistry and hematology values outside protocol specified range

• Positive QuantiFERON-tuberculosis (TB) Gold Test

• Evidence of active lung disease on chest x-ray

• Major systemic infections

• Presence of significant comorbid conditions

• Known allergy to latex

• Women who are pregnant or nursing