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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

851

Study ID:

NCT02376790

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 137 Locations for this study

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Tuscaloosa Alabama, 35406, United States
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Glendale Arizona, 85306, United States
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Mesa Arizona, 85202, United States
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Scottsdale Arizona, 85258, United States
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Little Rock Arkansas, 72205, United States
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Escondido California, 92025, United States
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Hemet California, 92543, United States
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Los Angeles California, 90095, United States
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Mather California, 95655, United States
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Palm Desert California, 92260, United States
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San Francisco California, 94143, United States
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Santa Monica California, 90404, United States
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Thousand Oaks California, 91360, United States
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Tustin California, 92780, United States
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Aventura Florida, 33180, United States
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Clearwater Florida, 33765, United States
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Kissimmee Florida, 34741, United States
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Ocoee Florida, 34761, United States
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Tampa Florida, 33609, United States
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Tampa Florida, 33613, United States
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Zephyrhills Florida, 33542, United States
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Meridian Idaho, 83642, United States
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Chicago Illinois, 60611, United States
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Springfield Illinois, 62703, United States
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Bowling Green Kentucky, 42101, United States
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Paducah Kentucky, 42003, United States
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Frederick Maryland, 21702, United States
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Hagerstown Maryland, 21740, United States
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Wheaton Maryland, 20902, United States
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Worcester Massachusetts, 01605, United States
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Lansing Michigan, 48910, United States
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Lansing Michigan, 48917, United States
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Saint Clair Shores Michigan, 48081, United States
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Rochester Minnesota, 55905, United States
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Las Vegas Nevada, 89128, United States
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Lebanon New Hampshire, 03756, United States
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Clifton New Jersey, 07012, United States
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Freehold New Jersey, 07728, United States
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Albuquerque New Mexico, 87102, United States
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New York New York, 10016, United States
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Rochester New York, 14642, United States
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Asheville North Carolina, 28803, United States
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Charlotte North Carolina, 28204, United States
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Cleveland Ohio, 44109, United States
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Oklahoma City Oklahoma, 73103, United States
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Duncansville Pennsylvania, 16635, United States
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Wyomissing Pennsylvania, 19610, United States
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Charleston South Carolina, 29406, United States
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Rapid City South Dakota, 57701, United States
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Dallas Texas, 75231, United States
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San Antonio Texas, 78232, United States
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Chesapeake Virginia, 23320, United States
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Danville Virginia, 24541, United States
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Roanoke Virginia, 24016, United States
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Seattle Washington, 98104, United States
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Ciudad Autonoma de Buenos Aires Buenos Aires, C1015, Argentina
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San Miguel de Tucuman Tucuman, T4000, Argentina
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Buenos Aires , 1425, Argentina
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Burgas , 8000, Bulgaria
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Pleven , 5800, Bulgaria
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Plovdiv , 4002, Bulgaria
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Rouse , 7002, Bulgaria
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Sofia , 1612, Bulgaria
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Sofia , 1784, Bulgaria
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Surrey British Columbia, V3R 6, Canada
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Winnipeg Manitoba, R3N 0, Canada
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London Ontario, N6A 3, Canada
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Toronto Ontario, M5T 2, Canada
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Trois-Rivieres Quebec, G8Z 1, Canada
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Saskatoon Saskatchewan, S7K 3, Canada
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Quebec , G1V 3, Canada
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Santiago , 75011, Chile
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Santiago , 76408, Chile
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Santiago , 84203, Chile
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Brno , 638 0, Czechia
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Ostrava-Trebovice , 722 0, Czechia
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Pardubice , 530 0, Czechia
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Praha 2 , 128 0, Czechia
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Praha 2 , 128 5, Czechia
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Uherske Hradiste , 686 0, Czechia
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Zlin , 760 0, Czechia
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Lyon Cédex 3 , 69437, France
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Poitiers , 86000, France
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Athens , 11521, Greece
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Athens , 11527, Greece
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Athens , 12462, Greece
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Thessaloniki , 56429, Greece
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Budapest , 1036, Hungary
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Nyiregyhaza , 4400, Hungary
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Szolnok , 5000, Hungary
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Szombathely , 9700, Hungary
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Veszprem , 8200, Hungary
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Liepaja , 3401, Latvia
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Riga , 1003, Latvia
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Valmiera , 4201, Latvia
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Mexicali Baja California Norte, 21100, Mexico
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Mexicalli Baja California Norte, 21200, Mexico
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Guadalajara Jalisco, 44650, Mexico
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Zapopan Jalisco, 45190, Mexico
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Monterrey Nuevo León, 64020, Mexico
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Monterrey Nuevo León, 64718, Mexico
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Culiacan Sinaloa, 80000, Mexico
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Chihuahua , 31000, Mexico
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Gdansk , 80-40, Poland
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Lodz , 90-43, Poland
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Warszawa , 01-81, Poland
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Wroclaw , 50-36, Poland
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Wroclaw , 51-31, Poland
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Lisboa , 1050-, Portugal
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Lisboa , 1649-, Portugal
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Ponte de Lima , 4990-, Portugal
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Ponce , 00716, Puerto Rico
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San Juan , 00918, Puerto Rico
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Chelyabinsk , 45407, Russian Federation
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Ekaterinburg , 62010, Russian Federation
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Kemerovo , 65000, Russian Federation
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Kursk , 30500, Russian Federation
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Moscow , 11552, Russian Federation
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Moscow , 11999, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Orenburg , 46001, Russian Federation
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Petrozavodsk , 18501, Russian Federation
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Ryazan , 39002, Russian Federation
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Saratov , 41005, Russian Federation
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Smolensk , 21402, Russian Federation
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Vladimir , 60002, Russian Federation
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Yaroslavl , 15000, Russian Federation
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Yaroslavl , 15006, Russian Federation
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Panorama Western Cape, 7500, South Africa
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Pinelands Western Cape, 7405, South Africa
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Stellenbosch Western Cape, 7600, South Africa
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Cordoba Andalucía, 14004, Spain
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La Vila-Joiosa Comunidad Valenciana, 03570, Spain
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Merida Extremadura, 06800, Spain
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A Coruña Galicia, 15006, Spain
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Bradford , BD5 0, United Kingdom
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Dudley , DY1 2, United Kingdom
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Nottingham , NG7 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

851

Study ID:

NCT02376790

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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