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



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2014
End Date:May 2016

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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:

- Male or female adults

- RA 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
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Glendale, Wisconsin 53217
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28210
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Duncansville, Pennsylvania 16635
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Great Neck, New York 11021
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Houston, Texas 77098
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Jonesboro, Arkansas 72401
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Lexington, Kentucky 40504
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Lincoln, Nebraska 68516
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Long Beach, California 90808
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Onalaska, Wisconsin 54650
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Palm Desert, California 92260
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1907 Tradd Ct
Wilmington, North Carolina 28401
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