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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Etanercept — DRUG
  Head-to-head comparison
• CHS-0214 — DRUG

Study Details

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 Dates

First listed

Apr 16, 2014

Start date

May 31, 2014

Status verified

Jun 2019

Primary completion

Oct 31, 2015

Completion

May 31, 2016

Study Design

Enrollment

647 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Enbrel (etanercept)
  Enbrel 50mg weekly times 24 weeks.
• Experimental: CHS-0214
  CHS-0214 50mg weekly times 24 weeks.

Primary Outcome Measure

ACR-20 - 20% Improvement According to American College of Rheumatology Criteria [ Time Frame: 24-weeks ]

Locations (37)

Find similar trials in Phoenix, AZ

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