Clinical trial NCT02115750: Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: CHS-0214
Enbrel
RA
Biosimilar
Etanercept
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2014-04-16
Enrollment: 647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
timeFrame: 24-weeks
Secondary outcomes:
measure: ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
timeFrame: Weeks 4, 8, 12 and 18
measure: Summary of Change in Tender Joint Count (TJC) by Study Visit
timeFrame: Weeks 4,8,12,18,24,28,36,48
measure: Summary of Change in Swollen Joint Count (SJC) by Study Visit
timeFrame: Weeks 4,8,12,18,24,28,36,48
measure: Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
timeFrame: Weeks 4,8,12,18,24,28,36,48
measure: Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
timeFrame: Weeks 4,8,12,18,24,28,36,48
measure: Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
timeFrame: Weeks 4,8,12,18,24,28,36,48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Dream Team Clinical Research
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research
state: California
city: Long Beach
country: United States
facility: Pro Health Partners
state: California
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Richmond
country: United States
facility: Kaiser Permanente - CA
state: California
city: Roseville
country: United States
facility: Med Investigators, Inc
state: California
city: Santa Monica
country: United States
facility: Troum Medical Associates
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Kissimmee
country: United States
facility: Hope Clinical Research
state: Florida
city: Orlando
country: United States
facility: Advanced Medical Research, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Allergy & Rheumatology Associates LLC
state: Florida
city: Tampa
country: United States
facility: HealthPoint Medical Group
state: Florida
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc
state: Kentucky
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Lincoln
country: United States
facility: Arthritis Center of Nebraska
state: Nebraska
city: Omaha
country: United States
facility: Pacific Arthritis Center Medical Group
state: Nebraska
city: Omaha
country: United States
facility: Rheumatoid Arthritis Investigational Network
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: North Shore University Hospital
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Arlington
country: United States
facility: Texas Physicians Medical Research Group
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology PLLC
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Onalaska
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Brest
country: Belarus
facility: Brest Regional Clinical Hospital
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Hospital
city: Grodno
country: Belarus
facility: Grodno Regional Clinical Hospital
city: Minsk
country: Belarus
facility: City Clinical Hospital #1 - Belarus
city: Minsk
country: Belarus
facility: City Clinical Hospital #9 - Belarus
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Grenoble
country: France
facility: Hôpital Michallon - CHU de Grenobl
city: Le Kremlin-Bicetre
country: France
facility: CHU Bicetre
city: Orleans Cedex
country: France
facility: Centre Hospitalier Regional D'Orleans
city: Paris
country: France
facility: Hopital Cochin-Saint Vincent de Paul
city: Saint-Etienne
country: France
facility: Hopital de Saint Etienne
city: Bad Abbach
country: Germany
facility: Asklepios Klinikum Bad Abbach
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Frankfurt
country: Germany
facility: Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
city: Gottingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Magdeburg
country: Germany
facility: SMO.MD GmbH - Zentrum fuer klinische Studien
city: Baja
country: Hungary
facility: St. Rokus Hospital, BAJA
city: Balatonfured
country: Hungary
facility: DRC Gyogzszervizsgalo Kozpont
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai es Fizioterapias Intezet
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház
city: Szeged
country: Hungary
facility: University of Szeged, Faculty of Medicine
city: Szikszo
country: Hungary
facility: Rakoczi Ferenc Korhaz-CRU Hungary (KFT)
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Takasaki-shi
country: Japan
facility: Inoue Hospital
state: Gunma
city: Nishi-ku
country: Japan
facility: Hiroshima Clinic
state: Hiroshimashi
city: Sendai-City
country: Japan
facility: Izumi Himawari Clinica
state: Miyagi
city: Omura-shi
country: Japan
facility: Miyashita Rheumatology Clinic
state: Nagasaki
city: Okayama-Shi
country: Japan
facility: Japanese Red Cross Okayama Hospital
state: Okayama
city: Aichi
country: Japan
facility: Japanese Red Cross Nagoya Daiichi Hospital
city: Ehime
country: Japan
facility: Yamada Rheumatology Clinic
city: Fukuoka-shi
country: Japan
facility: Shono Rheumatism Clinic
city: Fukuoka
country: Japan
facility: University of Occupational and Environmental Health Hospital
city: Fukuoka
country: Japan
facility: Kondo Clinic for Rheumatism and Orthopaedics
city: Fukuoka
country: Japan
facility: Medical Co. LTA PS Clinic
city: Fukuoka
country: Japan
facility: St Mary;s Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Rheumatology Clinic
city: Hyogo
country: Japan
facility: Medical Corporation Nakayama Clinic
city: Hyogo
country: Japan
facility: Matsubara Mayflower Hospital
city: Iwate
country: Japan
facility: Yoshida Orthopaedic and Rheumatology Clinic
city: Kagoshima
country: Japan
facility: Eiraku Clinic
city: Kagoshima
country: Japan
facility: Izumihara Rheumatic and Medical Clinic
city: Kanagawa
country: Japan
facility: Kawasaki Rheumatism and Internal Medicine Clinic
city: Kumamoto
country: Japan
facility: Kumamoto Orthopaedic Hospital
city: Miyagi
country: Japan
facility: Munakata Yasuhiko Clinic
city: Miyagi
country: Japan
facility: Yu-Family Clinic
city: Miyagi
country: Japan
facility: Sendai Taihaku Hospital
city: Miyazaki
country: Japan
facility: Kai Clinic
city: Miyazaki
country: Japan
facility: Zenjinkai Shimin no Mori Hospital
city: Morioka Iwate
country: Japan
facility: Komagamine Orthopaedic Rheumatic Clinic
city: Nagasaki
country: Japan
facility: Nagasaki Medical Hospital of Rheumatology
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagasaki
country: Japan
facility: SaSebo Chuo Hospital
city: Oita
country: Japan
facility: Oribe Clinic of Rheumatism and Medicine
city: Oita
country: Japan
facility: Otsuka Clinica of Rheumatism and Medicine
city: Osaka
country: Japan
facility: Rinku Hashimoto Rheumatology Orthopedics
city: Saitama
country: Japan
facility: Koshigaya Municipal Hospital
city: Saitama
country: Japan
facility: Medical Corporation Kojyokai Hirose Clinic
city: Sapporo
country: Japan
facility: Hokkaido Medical Center for Rheumatic Diseases
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Yamaguchi
country: Japan
facility: Miyasato Clinic
city: Yamaguchi
country: Japan
facility: Tokito Clinic Rheumatology and Orthopaedics, Surgery
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badan Klinicznych (MCBK) SC
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Kodz
country: Poland
facility: Centrum Terapii Wspólczesne
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED
city: Olsztyn
country: Poland
facility: Profmedicus sp. z o.o
city: Poznan
country: Poland
facility: Centrum Medyczne SYNEXUS Poznan
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Wroclaw
country: Poland
facility: Biogenes NZOZ
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Medical Academy
city: Moscow
country: Russian Federation
facility: State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov
city: Moscow
country: Russian Federation
facility: Practicheskaya Meditsina, Ltd
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a. V.A. Baranov
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University (SSMU)
city: St Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "Consultative diagnostic center #85
city: St. Petersburg
country: Russian Federation
facility: Medical Research Institute, LLC
city: Yaroslavl
country: Russian Federation
facility: Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev
city: Yekaterinburg
country: Russian Federation
facility: MBI "Central City Clinical Hospital #6
city: Cape Town
country: South Africa
facility: Dr CI Louw
city: Durban
country: South Africa
facility: Dr S Nayiager
city: Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Site
city: Mpumalanga
country: South Africa
facility: Drs Dindar and Partners
city: Pinelands
country: South Africa
facility: Private Practice - Cathy Spargo
city: Pretoria
country: South Africa
facility: Jakaranda Hospital Pretoria
city: Pretoria
country: South Africa
facility: Emmed Research
city: Stellenbosch
country: South Africa
facility: Winelands Rheumatology Centre
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate District NHS Foundation Trust
city: Merseyside
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Coherus Biosciences, Inc.
name: Barbara K Finck, M.D.
role: STUDY_DIRECTOR
References: