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

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ClinicalTrials.gov Identifier: NCT02115750
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Etanercept Drug: CHS-0214 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Active Comparator: Enbrel (etanercept)
Enbrel 50mg weekly times 24 weeks.
Drug: Etanercept
Head-to-head comparison
Other Names:
  • Enbrel
  • European Enbrel

Experimental: CHS-0214
CHS-0214 50mg weekly times 24 weeks.
Drug: CHS-0214



Primary Outcome Measures :
  1. ACR-20 [ Time Frame: 24-weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115750


  Show 141 Study Locations
Sponsors and Collaborators
Coherus Biosciences, Inc.
Daiichi Sankyo Co., Ltd.
Investigators
Study Director: Barbara K Finck, M.D. Coherus Biosciences, Inc.

Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02115750     History of Changes
Other Study ID Numbers: CHS-0214-02
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Coherus Biosciences, Inc.:
CHS-0214
Enbrel
RA
Biosimilar
Etanercept

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors