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

Information source: Coherus Biosciences, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug); CHS-0214 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Coherus Biosciences, Inc.

Official(s) and/or principal investigator(s):
Barbara K Finck, M.D., Study Director, Affiliation: Coherus Biosciences, Inc.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: ACR-20

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Brest Regional Clinical Hospital, Brest 224027, Belarus

Gomel Regional Clinical Hospital, Gomel 246029, Belarus

Grodno Regional Clinical Hospital, Grodno 230017, Belarus

City Clinical Hospital #1 - Belarus, Minsk 220013, Belarus

City Clinical Hospital #9 - Belarus, Minsk 220116, Belarus

Vitebsk Regional Clinical Hospital, Vitebsk 210037, Belarus

Hôpital Michallon - CHU de Grenobl, Grenoble 38434, France

CHU Bicetre, Le Kremlin-Bicetre 94275, France

Centre Hospitalier Regional D'Orleans, Orleans Cedex 45067, France

Hopital Cochin-Saint Vincent de Paul, Paris 75014, France

Hopital de Saint Etienne, Saint-Etienne 42055, France

Asklepios Klinikum Bad Abbach, Bad Abbach 93077, Germany

Klinische Forschung Dresden GmbH, Dresden 01069, Germany

Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology, Frankfurt 60528, Germany

Universitätsmedizin Göttingen, Gottingen 37075, Germany

SMO.MD GmbH - Zentrum fuer klinische Studien, Magdeburg 39112, Germany

St. Rokus Hospital, BAJA, Baja 6500, Hungary

DRC Gyogzszervizsgalo Kozpont, Balatonfured 8230, Hungary

Orszagos Reumatologiai es Fizioterapias Intezet, Budapest 1023, Hungary

Qualiclinic Kft, Budapest 1036, Hungary

Békés Megyei Pándy Kálmán Kórház, Gyula 5700, Hungary

University of Szeged, Faculty of Medicine, Szeged 6725, Hungary

Rakoczi Ferenc Korhaz-CRU Hungary (KFT), Szikszo 3800, Hungary

Rambam Medical Center, Haifa 3109601, Israel

Tel Aviv Sourasky Medical Center, Tel Aviv 64239, Israel

Sheba Medical Center, Tel Hashomer 52621, Israel

Assaf Harofeh Medical Center, Zerifin 70300, Israel

Japanese Red Cross Nagoya Daiichi Hospital, Aichi 453-8511, Japan

Yamada Rheumatology Clinic, Ehime 790-0905, Japan

Shono Rheumatism Clinic, Fukuoka-shi 814-002, Japan

Kondo Clinic for Rheumatism and Orthopaedics, Fukuoka 810-0001, Japan

Medical Co. LTA PS Clinic, Fukuoka 812-0025, Japan

St Mary;s Hospital, Fukuoka 830-8543, Japan

University of Occupational and Environmental Health Hospital, Fukuoka 807-8556, Japan

Hiroshima Rheumatology Clinic, Hiroshima 730-0017, Japan

Matsubara Mayflower Hospital, Hyogo 673-1462, Japan

Medical Corporation Nakayama Clinic, Hyogo 650-0044, Japan

Yoshida Orthopaedic and Rheumatology Clinic, Iwate 020-0015, Japan

Eiraku Clinic, Kagoshima 890-0055, Japan

Izumihara Rheumatic and Medical Clinic, Kagoshima 890-0067, Japan

Kawasaki Rheumatism and Internal Medicine Clinic, Kanagawa 212-0014, Japan

Kumamoto Orthopaedic Hospital, Kumamoto 862-0976, Japan

Munakata Yasuhiko Clinic, Miyagi 980-6166, Japan

Sendai Taihaku Hospital, Miyagi 982-0032, Japan

Yu-Family Clinic, Miyagi 981-0112, Japan

Kai Clinic, Miyazaki 880-0053, Japan

Zenjinkai Shimin no Mori Hospital, Miyazaki 880-0122, Japan

Komagamine Orthopaedic Rheumatic Clinic, Morioka Iwate 020-0034, Japan

Nagasaki Medical Hospital of Rheumatology, Nagasaki 850-0832, Japan

Nagasaki University Hospital, Nagasaki 852-8501, Japan

SaSebo Chuo Hospital, Nagasaki 857-1195, Japan

Oribe Clinic of Rheumatism and Medicine, Oita 870-0823, Japan

Otsuka Clinica of Rheumatism and Medicine, Oita 870-1155, Japan

Rinku Hashimoto Rheumatology Orthopedics, Osaka 598-0048, Japan

Koshigaya Municipal Hospital, Saitama 343-8577, Japan

Medical Corporation Kojyokai Hirose Clinic, Saitama 359-1111, Japan

Hokkaido Medical Center for Rheumatic Diseases, Sapporo 063-0811, Japan

Keio University Hospital, Tokyo 160-8582, Japan

St. Luke's International Hospital, Tokyo 104-8560, Japan

Miyasato Clinic, Yamaguchi 745-0824, Japan

Tokito Clinic Rheumatology and Orthopaedics, Surgery, Yamaguchi 752-0976, Japan

Centrum Kliniczno Badawcze, Elblag 82-300, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia 81-384, Poland

Mazowieckie Centrum Badan Klinicznych (MCBK) SC, Grodzisk Mazowiecki 05825, Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice 40-040, Poland

Centrum Terapii Wspólczesne, Kodz 90242, Poland

NZOZ Lecznica MAK-MED, Nadarzyn 05-830, Poland

Profmedicus sp. z o.o, Olsztyn 10696, Poland

Centrum Medyczne SYNEXUS Poznan, Poznan 60702, Poland

Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj, Poznan 61-639, Poland

Centrum Medyczne AMED, Warszawa 01518, Poland

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa 01-192, Poland

Biogenes NZOZ, Wroclaw 53-224, Poland

Synexus Polska Sp. z o.o, Wroclaw 53-413, Poland

Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg 620102, Russian Federation

Krasnoyarsk Medical Academy, Krasnoyarsk 660022, Russian Federation

Practicheskaya Meditsina, Ltd, Moscow 115404, Russian Federation

State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov, Moscow 111539, Russian Federation

Republican Hospital n.a. V.A. Baranov, Petrozavodsk 185019, Russian Federation

Smolensk State Medical University (SSMU), Smolensk 214019, Russian Federation

St. Petersburg State Healthcare Institution "Consultative diagnostic center #85, St Petersburg 198260, Russian Federation

Medical Research Institute, LLC, St. Petersburg 196084, Russian Federation

Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev, Yaroslavl 150003, Russian Federation

MBI "Central City Clinical Hospital #6, Yekaterinburg 620149, Russian Federation

Dr CI Louw, Cape Town 7500, South Africa

Dr S Nayiager, Durban 4001, South Africa

Wits Donald Gordon Clinical Trial Site, Johannesburg 2193, South Africa

Drs Dindar and Partners, Mpumalanga 2330, South Africa

Private Practice - Cathy Spargo, Pinelands 7405, South Africa

Emmed Research, Pretoria 0084, South Africa

Jakaranda Hospital Pretoria, Pretoria 0002, South Africa

Winelands Rheumatology Centre, Stellenbosch 7600, South Africa

Hospital La Paz, Madrid 28046, Spain

Hospital Universitario Ramon y Cajal, Madrid 28034, Spain

Hospital Regional Universitario de Málaga, Malaga 29009, Spain

Royal Sussex County Hospital, Brighton BN25PE, United Kingdom

Harrogate District NHS Foundation Trust, Harrogate HG27SX, United Kingdom

Wirral University Teaching Hospital NHS Foundation Trust, Merseyside CH495PE, United Kingdom

Nagoya University Hospital, Nagoya-shi, Aichi 466-8560, Japan

Arizona Research Center, Pheonix, Arizona 85020, United States

Elite Clinical Studies, Pheonix, Arizona 85018, United States

NEA Baptist Clinic, Jonesboro, Arkansas 72401, United States

Dream Team Clinical Research, Anaheim, California 92801, United States

Advanced Medical Research, Lakewood, California 90712, United States

Pro Health Partners, Long Beach, California 90808, United States

St. Joseph Hospital of Orange, Orange, California 92868, United States

Desert Medical Advances, Palm Desert, California 92260, United States

Kaiser Permanente - CA, Richmond, California 94801, United States

Med Investigators, Inc, Roseville, California 95661, United States

Troum Medical Associates, Santa Monica, California 90404, United States

Inland Rheumatology Clinical Trials Inc, Upland, California 91786, United States

IMMUNOe International Research Centers, Centennial, Colorado 80112, United States

Hope Clinical Research, Kissimmee, Florida 34741, United States

Advanced Medical Research, Inc, Orlando, Florida 32804, United States

Allergy & Rheumatology Associates LLC, Saint Petersburg, Florida 33708, United States

HealthPoint Medical Group, Tampa, Florida 33614, United States

Inoue Hospital, Takasaki-shi, Gunma 370-0053, Japan

Hiroshima Clinic, Nishi-ku, Hiroshimashi 733-0032, Japan

Bluegrass Community Research, Inc, Lexington, Kentucky 40504, United States

The Center for Rheumatology and Bone Research, Wheaton, Maryland 20902, United States

Clinical Pharmacology Study Group, Worchester, Massachusetts 01605, United States

St. Louis Center for Clinical Research, St. Louis, Missouri 63128, United States

Izumi Himawari Clinica, Sendai-City, Miyagi 981-3135, Japan

Miyashita Rheumatology Clinic, Omura-shi, Nagasaki 856-0836, Japan

Arthritis Center of Nebraska, Lincoln, Nebraska 68516, United States

Pacific Arthritis Center Medical Group, Omaha, Nebraska 68198, United States

Rheumatoid Arthritis Investigational Network, Omaha, Nebraska 68198, United States

Montefiore Medical Center, Bronx, New York 10467, United States

North Shore University Hospital, Great Neck, New York 11021, United States

DJL Clinical Research, Charlotte, North Carolina 28210, United States

PMG Research of Wilmington LLC, Wilmington, North Carolina 28401, United States

Japanese Red Cross Okayama Hospital, Okayama-Shi, Okayama 700-8607, Japan

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Low Country Rheumatology, Charleston, South Carolina 29406, United States

Arthritis Clinic, Jackson, Tennessee 38305, United States

Texas Physicians Medical Research Group, Arlington, Texas 76015, United States

Metroplex Clinical Research Center, Dallas, Texas 75231, United States

Pioneer Research Solutions Inc, Houston, Texas 77036, United States

Arthritis Northwest Rheumatology PLLC, Spokane, Washington 99204, United States

Rheumatic Disease Center, Glendale, Wisconsin 53217, United States

Gundersen Lutheran Medical Center, Onalaska, Wisconsin 54650, United States

Additional Information

Starting date: May 2014
Last updated: June 26, 2015

Page last updated: August 20, 2015

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