Psoriasis Clinical Trial
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Summary
The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.
Full Description
The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.
Eligibility Criteria
Key Inclusion Criteria:
Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
Subject has an active psoriatic skin lesion
Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
Subject has no prior use of methotrexate for PsA.
Subject has no history of tuberculosis
Subject has a negative test for tuberculosis, hepatitis B and C.
Exclusion Criteria:
Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.
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There are 137 Locations for this study
Tuscaloosa Alabama, 35406, United States
Glendale Arizona, 85306, United States
Mesa Arizona, 85202, United States
Scottsdale Arizona, 85258, United States
Little Rock Arkansas, 72205, United States
Escondido California, 92025, United States
Hemet California, 92543, United States
Los Angeles California, 90095, United States
Mather California, 95655, United States
Palm Desert California, 92260, United States
San Francisco California, 94143, United States
Santa Monica California, 90404, United States
Thousand Oaks California, 91360, United States
Tustin California, 92780, United States
Aventura Florida, 33180, United States
Clearwater Florida, 33765, United States
Kissimmee Florida, 34741, United States
Ocoee Florida, 34761, United States
Tampa Florida, 33609, United States
Tampa Florida, 33613, United States
Zephyrhills Florida, 33542, United States
Meridian Idaho, 83642, United States
Chicago Illinois, 60611, United States
Springfield Illinois, 62703, United States
Bowling Green Kentucky, 42101, United States
Paducah Kentucky, 42003, United States
Frederick Maryland, 21702, United States
Hagerstown Maryland, 21740, United States
Wheaton Maryland, 20902, United States
Worcester Massachusetts, 01605, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48917, United States
Saint Clair Shores Michigan, 48081, United States
Rochester Minnesota, 55905, United States
Las Vegas Nevada, 89128, United States
Lebanon New Hampshire, 03756, United States
Clifton New Jersey, 07012, United States
Freehold New Jersey, 07728, United States
Albuquerque New Mexico, 87102, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Asheville North Carolina, 28803, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44109, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Wyomissing Pennsylvania, 19610, United States
Charleston South Carolina, 29406, United States
Rapid City South Dakota, 57701, United States
Dallas Texas, 75231, United States
San Antonio Texas, 78232, United States
Chesapeake Virginia, 23320, United States
Danville Virginia, 24541, United States
Roanoke Virginia, 24016, United States
Seattle Washington, 98104, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1015, Argentina
San Miguel de Tucuman Tucuman, T4000, Argentina
Buenos Aires , 1425, Argentina
Burgas , 8000, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Rouse , 7002, Bulgaria
Sofia , 1612, Bulgaria
Sofia , 1784, Bulgaria
Surrey British Columbia, V3R 6, Canada
Winnipeg Manitoba, R3N 0, Canada
London Ontario, N6A 3, Canada
Toronto Ontario, M5T 2, Canada
Trois-Rivieres Quebec, G8Z 1, Canada
Saskatoon Saskatchewan, S7K 3, Canada
Quebec , G1V 3, Canada
Santiago , 75011, Chile
Santiago , 76408, Chile
Santiago , 84203, Chile
Brno , 638 0, Czechia
Ostrava-Trebovice , 722 0, Czechia
Pardubice , 530 0, Czechia
Praha 2 , 128 0, Czechia
Praha 2 , 128 5, Czechia
Uherske Hradiste , 686 0, Czechia
Zlin , 760 0, Czechia
Lyon Cédex 3 , 69437, France
Poitiers , 86000, France
Athens , 11521, Greece
Athens , 11527, Greece
Athens , 12462, Greece
Thessaloniki , 56429, Greece
Budapest , 1036, Hungary
Nyiregyhaza , 4400, Hungary
Szolnok , 5000, Hungary
Szombathely , 9700, Hungary
Veszprem , 8200, Hungary
Liepaja , 3401, Latvia
Riga , 1003, Latvia
Valmiera , 4201, Latvia
Mexicali Baja California Norte, 21100, Mexico
Mexicalli Baja California Norte, 21200, Mexico
Guadalajara Jalisco, 44650, Mexico
Zapopan Jalisco, 45190, Mexico
Monterrey Nuevo León, 64020, Mexico
Monterrey Nuevo León, 64718, Mexico
Culiacan Sinaloa, 80000, Mexico
Chihuahua , 31000, Mexico
Gdansk , 80-40, Poland
Lodz , 90-43, Poland
Warszawa , 01-81, Poland
Wroclaw , 50-36, Poland
Wroclaw , 51-31, Poland
Lisboa , 1050-, Portugal
Lisboa , 1649-, Portugal
Ponte de Lima , 4990-, Portugal
Ponce , 00716, Puerto Rico
San Juan , 00918, Puerto Rico
Chelyabinsk , 45407, Russian Federation
Ekaterinburg , 62010, Russian Federation
Kemerovo , 65000, Russian Federation
Kursk , 30500, Russian Federation
Moscow , 11552, Russian Federation
Moscow , 11999, Russian Federation
Novosibirsk , 63000, Russian Federation
Orenburg , 46001, Russian Federation
Petrozavodsk , 18501, Russian Federation
Ryazan , 39002, Russian Federation
Saratov , 41005, Russian Federation
Smolensk , 21402, Russian Federation
Vladimir , 60002, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15006, Russian Federation
Panorama Western Cape, 7500, South Africa
Pinelands Western Cape, 7405, South Africa
Stellenbosch Western Cape, 7600, South Africa
Cordoba AndalucÃa, 14004, Spain
La Vila-Joiosa Comunidad Valenciana, 03570, Spain
Merida Extremadura, 06800, Spain
A Coruña Galicia, 15006, Spain
Bradford , BD5 0, United Kingdom
Dudley , DY1 2, United Kingdom
Nottingham , NG7 2, United Kingdom
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