NCT02115750

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 647 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept	Head-to-head comparison
DRUG	CHS-0214

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-10-01
• Completion: 2016-05-01
• First posted: 2014-04-16
• Last updated: 2019-06-26
• Results posted: 2019-06-26

Locations

141 sites across 12 countries: United States, Belarus, France, Germany, Hungary, Israel, Japan, Poland, Russia, South Africa, Spain, United Kingdom