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

Last updated: June 7, 2019
Sponsor: Coherus Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT02115750
CHS-0214-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 647
Study Start date:
May 01, 2014
Estimated Completion Date:
May 31, 2016

Connect with a study center

  • Brest Regional Clinical Hospital

    Brest, 224027
    Belarus

    Site Not Available

  • Gomel Regional Clinical Hospital

    Gomel, 246029
    Belarus

    Site Not Available

  • Grodno Regional Clinical Hospital

    Grodno, 230017
    Belarus

    Site Not Available

  • City Clinical Hospital #1 - Belarus

    Minsk, 220013
    Belarus

    Site Not Available

  • City Clinical Hospital #9 - Belarus

    Minsk, 220116
    Belarus

    Site Not Available

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037
    Belarus

    Site Not Available

  • Hôpital Michallon - CHU de Grenobl

    Grenoble, 38434
    France

    Site Not Available

  • CHU Bicetre

    Le Kremlin-Bicetre, 94275
    France

    Site Not Available

  • Centre Hospitalier Regional D'Orleans

    Orleans Cedex, 45067
    France

    Site Not Available

  • Hopital Cochin-Saint Vincent de Paul

    Paris, 75014
    France

    Site Not Available

  • Hopital de Saint Etienne

    Saint-Etienne, 42055
    France

    Site Not Available

  • Asklepios Klinikum Bad Abbach

    Bad Abbach, 93077
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, 01069
    Germany

    Site Not Available

  • Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

    Frankfurt, 60528
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen

    Gottingen, 37075
    Germany

    Site Not Available

  • SMO.MD GmbH - Zentrum fuer klinische Studien

    Magdeburg, 39112
    Germany

    Site Not Available

  • St. Rokus Hospital, BAJA

    Baja, 6500
    Hungary

    Site Not Available

  • DRC Gyogzszervizsgalo Kozpont

    Balatonfured, 8230
    Hungary

    Site Not Available

  • Orszagos Reumatologiai es Fizioterapias Intezet

    Budapest, 1023
    Hungary

    Site Not Available

  • Qualiclinic Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, 5700
    Hungary

    Site Not Available

  • University of Szeged, Faculty of Medicine

    Szeged, 6725
    Hungary

    Site Not Available

  • Rakoczi Ferenc Korhaz-CRU Hungary (KFT)

    Szikszo, 3800
    Hungary

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Nagoya University Hospital

    Nagoya-shi, Aichi 466-8560
    Japan

    Site Not Available

  • Inoue Hospital

    Takasaki-shi, Gunma 370-0053
    Japan

    Site Not Available

  • Hiroshima Clinic

    Nishi-ku, Hiroshimashi 733-0032
    Japan

    Site Not Available

  • Izumi Himawari Clinica

    Sendai-City, Miyagi 981-3135
    Japan

    Site Not Available

  • Miyashita Rheumatology Clinic

    Omura-shi, Nagasaki 856-0836
    Japan

    Site Not Available

  • Japanese Red Cross Okayama Hospital

    Okayama-Shi, Okayama 700-8607
    Japan

    Site Not Available

  • Japanese Red Cross Nagoya Daiichi Hospital

    Aichi, 453-8511
    Japan

    Site Not Available

  • Yamada Rheumatology Clinic

    Ehime, 790-0905
    Japan

    Site Not Available

  • Kondo Clinic for Rheumatism and Orthopaedics

    Fukuoka, 810-0001
    Japan

    Site Not Available

  • Medical Co. LTA PS Clinic

    Fukuoka, 812-0025
    Japan

    Site Not Available

  • St Mary;s Hospital

    Fukuoka, 830-8543
    Japan

    Site Not Available

  • University of Occupational and Environmental Health Hospital

    Fukuoka, 807-8556
    Japan

    Site Not Available

  • Shono Rheumatism Clinic

    Fukuoka-shi, 814-002
    Japan

    Site Not Available

  • Hiroshima Rheumatology Clinic

    Hiroshima, 730-0017
    Japan

    Site Not Available

  • Matsubara Mayflower Hospital

    Hyogo, 673-1462
    Japan

    Site Not Available

  • Medical Corporation Nakayama Clinic

    Hyogo, 650-0044
    Japan

    Site Not Available

  • Yoshida Orthopaedic and Rheumatology Clinic

    Iwate, 020-0015
    Japan

    Site Not Available

  • Eiraku Clinic

    Kagoshima, 890-0055
    Japan

    Site Not Available

  • Izumihara Rheumatic and Medical Clinic

    Kagoshima, 890-0067
    Japan

    Site Not Available

  • Kawasaki Rheumatism and Internal Medicine Clinic

    Kanagawa, 212-0014
    Japan

    Site Not Available

  • Kumamoto Orthopaedic Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Munakata Yasuhiko Clinic

    Miyagi, 980-6166
    Japan

    Site Not Available

  • Sendai Taihaku Hospital

    Miyagi, 982-0032
    Japan

    Site Not Available

  • Yu-Family Clinic

    Miyagi, 981-0112
    Japan

    Site Not Available

  • Kai Clinic

    Miyazaki, 880-0053
    Japan

    Site Not Available

  • Zenjinkai Shimin no Mori Hospital

    Miyazaki, 880-0122
    Japan

    Site Not Available

  • Komagamine Orthopaedic Rheumatic Clinic

    Morioka Iwate, 020-0034
    Japan

    Site Not Available

  • Nagasaki Medical Hospital of Rheumatology

    Nagasaki, 850-0832
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • SaSebo Chuo Hospital

    Nagasaki, 857-1195
    Japan

    Site Not Available

  • Oribe Clinic of Rheumatism and Medicine

    Oita, 870-0823
    Japan

    Site Not Available

  • Otsuka Clinica of Rheumatism and Medicine

    Oita, 870-1155
    Japan

    Site Not Available

  • Rinku Hashimoto Rheumatology Orthopedics

    Osaka, 598-0048
    Japan

    Site Not Available

  • Koshigaya Municipal Hospital

    Saitama, 343-8577
    Japan

    Site Not Available

  • Medical Corporation Kojyokai Hirose Clinic

    Saitama, 359-1111
    Japan

    Site Not Available

  • Hokkaido Medical Center for Rheumatic Diseases

    Sapporo, 063-0811
    Japan

    Site Not Available

  • Keio University Hospital

    Tokyo, 160-8582
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Tokyo, 104-8560
    Japan

    Site Not Available

  • Miyasato Clinic

    Yamaguchi, 745-0824
    Japan

    Site Not Available

  • Tokito Clinic Rheumatology and Orthopaedics, Surgery

    Yamaguchi, 752-0976
    Japan

    Site Not Available

  • Centrum Medyczne SILESIANA Sp. z o.o

    Bytom, 41902
    Poland

    Site Not Available

  • Centrum Kliniczno Badawcze

    Elblag, 82-300
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-384
    Poland

    Site Not Available

  • Mazowieckie Centrum Badan Klinicznych (MCBK) SC

    Grodzisk Mazowiecki, 05825
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040
    Poland

    Site Not Available

  • Centrum Terapii Wspólczesne

    Kodz, 90242
    Poland

    Site Not Available

  • Specjalistyczny Osrodek ALL-MED

    Krakow, 31013
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Profmedicus sp. z o.o

    Olsztyn, 10696
    Poland

    Site Not Available

  • Centrum Medyczne SYNEXUS Poznan

    Poznan, 60702
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj

    Poznan, 61-639
    Poland

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszow, 35055
    Poland

    Site Not Available

  • Centrum Medyczne AMED

    Warszawa, 01518
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warszawa, 01-192
    Poland

    Site Not Available

  • Biogenes NZOZ

    Wroclaw, 53-224
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o

    Wroclaw, 53-413
    Poland

    Site Not Available

  • Sverdlovsk Regional Clinical Hospital #1

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • Krasnoyarsk Medical Academy

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • Practicheskaya Meditsina, Ltd

    Moscow, 115404
    Russian Federation

    Site Not Available

  • State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov

    Moscow, 111539
    Russian Federation

    Site Not Available

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, 185019
    Russian Federation

    Site Not Available

  • Smolensk State Medical University (SSMU)

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • St. Petersburg State Healthcare Institution "Consultative diagnostic center #85

    St Petersburg, 198260
    Russian Federation

    Site Not Available

  • Medical Research Institute, LLC

    St. Petersburg, 196084
    Russian Federation

    Site Not Available

  • Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • MBI "Central City Clinical Hospital #6

    Yekaterinburg, 620149
    Russian Federation

    Site Not Available

  • Dr CI Louw

    Cape Town, 7500
    South Africa

    Site Not Available

  • Dr S Nayiager

    Durban, 4001
    South Africa

    Site Not Available

  • Wits Donald Gordon Clinical Trial Site

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Drs Dindar and Partners

    Mpumalanga, 2330
    South Africa

    Site Not Available

  • Private Practice - Cathy Spargo

    Pinelands, 7405
    South Africa

    Site Not Available

  • Emmed Research

    Pretoria, 0084
    South Africa

    Site Not Available

  • Jakaranda Hospital Pretoria

    Pretoria, 0002
    South Africa

    Site Not Available

  • Winelands Rheumatology Centre

    Stellenbosch, 7600
    South Africa

    Site Not Available

  • Hospital La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Malaga, 29009
    Spain

    Site Not Available

  • Royal Sussex County Hospital

    Brighton, BN25PE
    United Kingdom

    Site Not Available

  • Harrogate District NHS Foundation Trust

    Harrogate, HG27SX
    United Kingdom

    Site Not Available

  • Wirral University Teaching Hospital NHS Foundation Trust

    Merseyside, CH495PE
    United Kingdom

    Site Not Available

  • Warrington Hospital

    Warrington, WA51QG
    United Kingdom

    Site Not Available

  • Arizona Research Center

    Pheonix, Arizona 85020
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Elite Clinical Studies

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • NEA Baptist Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Dream Team Clinical Research

    Anaheim, California 92801
    United States

    Site Not Available

  • Advanced Medical Research

    Lakewood, California 90712
    United States

    Site Not Available

  • Pro Health Partners

    Long Beach, California 90808
    United States

    Site Not Available

  • St. Joseph Hospital of Orange

    Orange, California 92868
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California 92260
    United States

    Site Not Available

  • Kaiser Permanente - CA

    Richmond, California 94801
    United States

    Site Not Available

  • Med Investigators, Inc

    Roseville, California 95661
    United States

    Site Not Available

  • Troum Medical Associates

    Santa Monica, California 90404
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials Inc

    Upland, California 91786
    United States

    Site Not Available

  • IMMUNOe International Research Centers

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Hope Clinical Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Advanced Medical Research, Inc

    Orlando, Florida 32804
    United States

    Site Not Available

  • Allergy & Rheumatology Associates LLC

    Saint Petersburg, Florida 33708
    United States

    Site Not Available

  • HealthPoint Medical Group

    Tampa, Florida 33614
    United States

    Site Not Available

  • Bluegrass Community Research, Inc

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worchester, Massachusetts 01605
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Arthritis Center of Nebraska

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Pacific Arthritis Center Medical Group

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Rheumatoid Arthritis Investigational Network

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • North Shore University Hospital

    Great Neck, New York 11021
    United States

    Site Not Available

  • DJL Clinical Research

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • PMG Research of Wilmington LLC

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Low Country Rheumatology

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Arthritis Clinic

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Texas Physicians Medical Research Group

    Arlington, Texas 76015
    United States

    Site Not Available

  • Metroplex Clinical Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Pioneer Research Solutions Inc

    Houston, Texas 77036
    United States

    Site Not Available

  • Arthritis Northwest Rheumatology PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

  • Mountain State Clinical Research

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Site Not Available

  • Gundersen Lutheran Medical Center

    Onalaska, Wisconsin 54650
    United States

    Site Not Available

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