Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02)

  • STATUS
    Recruiting
  • sponsor
    Coherus
Updated on 8 November 2020

Summary

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02)

Description

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.

Details
Condition Rheumatoid Arthritis
Clinical Study IdentifierTX138615
SponsorCoherus
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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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