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

Coherus BioSciences

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: CHS-0214; Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02115750

CHS-0214-02

Details and patient eligibility

About

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.

Enrollment: 647 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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647 participants in 2 patient groups

Enbrel (etanercept)

Active Comparator group

Description:

Enbrel 50mg weekly times 24 weeks.

Treatment:

Drug: Etanercept

CHS-0214

Experimental group

Description:

CHS-0214 50mg weekly times 24 weeks.

Treatment:

Drug: CHS-0214