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

NCT02115750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2019-06-26

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Etanercept

Head-to-head comparison

DRUG

CHS-0214

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Coherus Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara K Finck, M.D. · Coherus Oncology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-10-31
Completion
2016-05-31

Countries

  • United States
  • Belarus
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Poland
  • Russia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115750 on ClinicalTrials.gov