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