Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT02115750
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
647 participants
INTERVENTIONAL
2014-05-31
2016-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enbrel (etanercept)
Enbrel 50mg weekly times 24 weeks.
Etanercept
Head-to-head comparison
CHS-0214
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
Interventions
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Etanercept
Head-to-head comparison
CHS-0214
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Coherus Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara K Finck, M.D.
Role: STUDY_DIRECTOR
Coherus Oncology, Inc.
Locations
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Elite Clinical Studies
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Dream Team Clinical Research
Anaheim, California, United States
Advanced Medical Research
Lakewood, California, United States
Pro Health Partners
Long Beach, California, United States
St. Joseph Hospital of Orange
Orange, California, United States
Desert Medical Advances
Palm Desert, California, United States
Kaiser Permanente - CA
Richmond, California, United States
Med Investigators, Inc
Roseville, California, United States
Troum Medical Associates
Santa Monica, California, United States
Inland Rheumatology Clinical Trials Inc
Upland, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
Hope Clinical Research
Kissimmee, Florida, United States
Advanced Medical Research, Inc
Orlando, Florida, United States
Allergy & Rheumatology Associates LLC
St. Petersburg, Florida, United States
HealthPoint Medical Group
Tampa, Florida, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, United States
Pacific Arthritis Center Medical Group
Omaha, Nebraska, United States
Rheumatoid Arthritis Investigational Network
Omaha, Nebraska, United States
North Shore University Hospital
Great Neck, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
Texas Physicians Medical Research Group
Arlington, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
Arthritis Northwest Rheumatology PLLC
Spokane, Washington, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Gundersen Lutheran Medical Center
Onalaska, Wisconsin, United States
Brest Regional Clinical Hospital
Brest, , Belarus
Grodno Regional Clinical Hospital
Grodno, , Belarus
Gomel Regional Clinical Hospital
Homyel, , Belarus
City Clinical Hospital #1 - Belarus
Minsk, , Belarus
City Clinical Hospital #9 - Belarus
Minsk, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
Hôpital Michallon - CHU de Grenobl
Grenoble, , France
CHU Bicetre
Le Kremlin-Bicêtre, , France
Centre Hospitalier Regional D'Orleans
Orléans, , France
Hopital Cochin-Saint Vincent de Paul
Paris, , France
Hopital de Saint Etienne
Saint-Etienne, , France
Asklepios Klinikum Bad Abbach
Bad Abbach, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
Frankfurt, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
SMO.MD GmbH - Zentrum fuer klinische Studien
Magdeburg, , Germany
St. Rokus Hospital, BAJA
Baja, , Hungary
DRC Gyogzszervizsgalo Kozpont
Balatonfüred, , Hungary
Orszagos Reumatologiai es Fizioterapias Intezet
Budapest, , Hungary
Qualiclinic Kft
Budapest, , Hungary
Békés Megyei Pándy Kálmán Kórház
Gyula, , Hungary
University of Szeged, Faculty of Medicine
Szeged, , Hungary
Rakoczi Ferenc Korhaz-CRU Hungary (KFT)
Szikszó, , Hungary
Rambam Medical Center
Haifa, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Inoue Hospital
Takasaki-shi, Gunma, Japan
Hiroshima Clinic
Nishiku, Hiroshimashi, Japan
Izumi Himawari Clinica
Sendai, Miyagi, Japan
Miyashita Rheumatology Clinic
Omura-shi, Nagasaki, Japan
Japanese Red Cross Okayama Hospital
Okayama, Okayama-ken, Japan
Japanese Red Cross Nagoya Daiichi Hospital
Aichi, , Japan
Yamada Rheumatology Clinic
Ehime, , Japan
University of Occupational and Environmental Health Hospital
Fukuoka, , Japan
Kondo Clinic for Rheumatism and Orthopaedics
Fukuoka, , Japan
Medical Co. LTA PS Clinic
Fukuoka, , Japan
Shono Rheumatism Clinic
Fukuoka, , Japan
St Mary;s Hospital
Fukuoka, , Japan
Hiroshima Rheumatology Clinic
Hiroshima, , Japan
Medical Corporation Nakayama Clinic
Hyōgo, , Japan
Matsubara Mayflower Hospital
Hyōgo, , Japan
Eiraku Clinic
Kagoshima, , Japan
Izumihara Rheumatic and Medical Clinic
Kagoshima, , Japan
Kawasaki Rheumatism and Internal Medicine Clinic
Kanagawa, , Japan
Kumamoto Orthopaedic Hospital
Kumamoto, , Japan
Munakata Yasuhiko Clinic
Miyagi, , Japan
Yu-Family Clinic
Miyagi, , Japan
Sendai Taihaku Hospital
Miyagi, , Japan
Kai Clinic
Miyazaki, , Japan
Zenjinkai Shimin no Mori Hospital
Miyazaki, , Japan
Komagamine Orthopaedic Rheumatic Clinic
Morioka Iwate, , Japan
Nagasaki Medical Hospital of Rheumatology
Nagasaki, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
SaSebo Chuo Hospital
Nagasaki, , Japan
Yoshida Orthopaedic and Rheumatology Clinic
Numakunai, , Japan
Rinku Hashimoto Rheumatology Orthopedics
Osaka, , Japan
Oribe Clinic of Rheumatism and Medicine
Ōita, , Japan
Otsuka Clinica of Rheumatism and Medicine
Ōita, , Japan
Koshigaya Municipal Hospital
Saitama, , Japan
Medical Corporation Kojyokai Hirose Clinic
Saitama, , Japan
Hokkaido Medical Center for Rheumatic Diseases
Sapporo, , Japan
St. Luke's International Hospital
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Miyasato Clinic
Yamaguchi, , Japan
Tokito Clinic Rheumatology and Orthopaedics, Surgery
Yamaguchi, , Japan
Centrum Kliniczno Badawcze
Elblag, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
Mazowieckie Centrum Badan Klinicznych (MCBK) SC
Grodzisk Mazowiecki, , Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Centrum Terapii Wspólczesne
Kodz, , Poland
NZOZ Lecznica MAK-MED
Nadarzyn, , Poland
Profmedicus sp. z o.o
Olsztyn, , Poland
Centrum Medyczne SYNEXUS Poznan
Poznan, , Poland
Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj
Poznan, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Biogenes NZOZ
Wroclaw, , Poland
Synexus Polska Sp. z o.o
Wroclaw, , Poland
Krasnoyarsk Medical Academy
Krasnoyarsk, , Russia
State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov
Moscow, , Russia
Practicheskaya Meditsina, Ltd
Moscow, , Russia
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, , Russia
Medical Research Institute, LLC
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "Consultative diagnostic center #85
Saint Petersburg, , Russia
Smolensk State Medical University (SSMU)
Smolensk, , Russia
Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev
Yaroslavl, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
MBI "Central City Clinical Hospital #6
Yekaterinburg, , Russia
Dr CI Louw
Cape Town, , South Africa
Dr S Nayiager
Durban, , South Africa
Wits Donald Gordon Clinical Trial Site
Johannesburg, , South Africa
Drs Dindar and Partners
Mpumalanga, , South Africa
Private Practice - Cathy Spargo
Pinelands, , South Africa
Jakaranda Hospital Pretoria
Pretoria, , South Africa
Emmed Research
Pretoria, , South Africa
Winelands Rheumatology Centre
Stellenbosch, , South Africa
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Royal Sussex County Hospital
Brighton, , United Kingdom
Harrogate District NHS Foundation Trust
Harrogate, , United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Merseyside, , United Kingdom
Countries
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Other Identifiers
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CHS-0214-02
Identifier Type: -
Identifier Source: org_study_id
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