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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02115750

Run by

Coherus Oncology, Inc.

People needed

647

Starts

2014-05-01

Expected to finish

2016-05-01

Last updated by the study team

2019-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Dream Team Clinical Research — Anaheim, California, United States
• Advanced Medical Research — Lakewood, California, United States
• Pro Health Partners — Long Beach, California, United States
• St. Joseph Hospital of Orange — Orange, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Kaiser Permanente - CA — Richmond, California, United States
• Med Investigators, Inc — Roseville, California, United States
• Troum Medical Associates — Santa Monica, California, United States
• Inland Rheumatology Clinical Trials Inc — Upland, California, United States
• IMMUNOe International Research Centers — Centennial, Colorado, United States
• Hope Clinical Research — Kissimmee, Florida, United States
• Advanced Medical Research, Inc — Orlando, Florida, United States
• Allergy & Rheumatology Associates LLC — St. Petersburg, Florida, United States
• HealthPoint Medical Group — Tampa, Florida, United States
• Bluegrass Community Research, Inc — Lexington, Kentucky, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• St. Louis Center for Clinical Research — St Louis, Missouri, United States
• Arthritis Center of Nebraska — Lincoln, Nebraska, United States
• Pacific Arthritis Center Medical Group — Omaha, Nebraska, United States
• Rheumatoid Arthritis Investigational Network — Omaha, Nebraska, United States
• North Shore University Hospital — Great Neck, New York, United States
• Elite Clinical Studies — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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