Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
NCT ID: NCT02134210
Last Updated: 2019-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
521 participants
INTERVENTIONAL
2014-06-16
2016-05-12
Brief Summary
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Detailed Description
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Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.
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 twice weekly times 12 weeks
Etanercept
Head-to-head comparison
CHS-0214
CHS-0214 50mg twice weekly times 12 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
* PsO diagnosis for 6 months
* Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),
* Body Surface Area (BSA) involved with PsO greater than or equal to 10%
* Dermatology Life Quality Index (DQLI) greater than or equal to 10
* Previously received phototherapy or systemic non-biologic therapy for PsO
Exclusion Criteria
* Drug induced Psoriasis
* Positive QuantiFERON-tuberculosis (TB) Gold Test
* Presence of significant comorbid conditions
* Chemistry and hematology values outside protocol specified range
* Major systemic infections
18 Years
ALL
No
Sponsors
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Shire
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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Arizona Research Center
Phoenix, Arizona, United States
Radiant Research - Scottsdale
Scottsdale, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Dream Team Clinical Research
Anaheim, California, United States
Private Practice
Encino, California, United States
Kaiser Permanente
Los Angeles, California, United States
Skin Surgery Medical Group, Inc
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Healthcare Partners Medical Group
Torrance, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
The Savin Center
New Haven, Connecticut, United States
New England Research Associates
Trumbull, Connecticut, United States
Florida Academic Dermatology Center (U of Miami Hospital)
Miami, Florida, United States
Radiant Research - Pinellas Park
Pinellas Park, Florida, United States
Atlantic Clinical Research Collaborative
West Palm Beach, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Radiant Research - Atlanta
Atlanta, Georgia, United States
Private Practice - Jamie Weisman
Atlanta, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Kansas City Dermatology
Overland Park, Kansas, United States
Derm Research
Louisville, Kentucky, United States
Hamzavi Dermatology Clinical Research
Fort Gratiot, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Radiant Research - Edina
Edina, Minnesota, United States
Central Dermatology
St Louis, Missouri, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Skin Search of Rochester, Inc
Rochester, New York, United States
DermResearch Center of New York
Stony Brook, New York, United States
PMG Research of Carey, LLC
Cary, North Carolina, United States
DJL Clinical Research
Charlotte, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clincal Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States
Radiant Research - Anderson
Anderson, South Carolina, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, United States
Radient Research - Greer
Greer, South Carolina, United States
Rivergate Dermatology
Goodlettsville, Tennessee, United States
Neighborhood Medical Center
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Heights Dermatology and Aesthetic Center
Houston, Texas, United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Dermatology Associates, PLLC
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Woden Dermatology Pty
Phillip, Australian Capital Territory, Australia
Dr S P Shumack (St George Dermatology and Skin Cancer Center)
Kogarah, New South Wales, Australia
Dr S P Shumack (Central Sydney Dermatology)
Sydney, New South Wales, Australia
North Eastern Health Specialists
Hectorville, South Australia, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
E and D Woolner Professional Corporation
Calgary, Alberta, Canada
Institute for Skin Advancement Inc
Calgary, Alberta, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
North Bay Dermatology Centre Inc
North Bay, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
SKiN Center for Dermatology
Peterborough, Ontario, Canada
Private Practice
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow
Berlin, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Hautklinik Universitaetsklinikum Erlangen
Erlangen, , Germany
Johann Wolfgang Hospital - Goethe University
Frankfurt, , Germany
Dermatologikum Hamburg
Hamburg, , Germany
University Hospital Schleswig-Holstein - Campus Luebeck
Lübeck, , Germany
Haemek Medical Center
Afula, , Israel
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Bialystok, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorób Kostno-Stawowych J. Badurski S.J
Bialystok, , Poland
Centrum Badan Klinicznych PI-House Sp. Z o.o
Gdansk, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Specjalistyczny Osrodek ALL-MED
Krakow, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
Center Med
Krakow, , Poland
Specjalistyczne Gabinety Lekarskie "Dermed
Lodz, , Poland
Centrum Medyczne SYNEXUS POZNAN
Poznan, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
SANUS Szpital Specjalistyczny Sp. z o.o
Stalowa Wola, , Poland
EuroMedis Sp. z o.o.
Szczecin, , Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy z Przychodnia Specjalistyczna
Torun, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Synexus Polska sp. z o.o
Wroclaw, , Poland
Dermmedica Sp. z o.o
Wroclaw, , Poland
Vincent Pallotti Hospital
Pinelands, Cape Town, South Africa
Synopsis Research
Rondebosch, Cape Town, South Africa
Jongaie Research
Pretoria West, Pretoria, South Africa
Helderberg Clinical Trial Centre
Somerset West, Western Cape, South Africa
Dr IC Louw
Cape Town, , South Africa
Winelands Rheumatology Centre
Stellenbosch, , South Africa
Clinical Projects Research
Worcester, , South Africa
Countries
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Other Identifiers
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CHS-0214-04
Identifier Type: -
Identifier Source: org_study_id
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