Psoriasis Clinical Trial
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Summary
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
Eligibility Criteria
Inclusion Criteria:
Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least
1 psoriatic skin lesion. Exclusion Criteria:
• -Subject has known history of active tuberculosis.
Subject has a planned surgical intervention between baseline and the week 52 evaluation.
Subject has an active infection or history of infections.
Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.
Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
• Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
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There are 103 Locations for this study
Peoria Arizona, 85381, United States
Little Rock Arkansas, 72205, United States
Cypress California, 90630, United States
Hemet California, 92543, United States
Huntington Beach California, 92646, United States
La Jolla California, 92037, United States
Palm Desert California, 92260, United States
Palo Alto California, 94304, United States
Victorville California, 92395, United States
Saint Petersburg Florida, 33705, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Tampa Florida, 33614, United States
Chicago Illinois, 60611, United States
Paducah Kentucky, 42003, United States
Baton Rouge Louisiana, 70809, United States
Wheaton Maryland, 20902, United States
Boston Massachusetts, 02111, United States
Battle Creek Michigan, 49017, United States
Grand Rapids Michigan, 49546, United States
Lansing Michigan, 48910, United States
Saint Louis Missouri, 63141, United States
Las Vegas Nevada, 89102, United States
Rochester New York, 14642, United States
Oklahoma City Oklahoma, 73103, United States
Tulsa Oklahoma, 74104, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Waco Texas, 76708, United States
Chesapeake Virginia, 23320, United States
Seattle Washington, 98104, United States
Calgary Alberta, T3A 2, Canada
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3A 1, Canada
St. John's Newfoundland and Labrador, A1A 5, Canada
St. John's Newfoundland and Labrador, A1C 5, Canada
Waterloo Ontario, N2J 1, Canada
Trois-Rivieres Quebec, G8Z 1, Canada
Quebec , G1V 3, Canada
Quebec , G1V 4, Canada
Bordeaux Cedex , 33076, France
Le Kremlin Bicetre , 94270, France
Lille cedex , 59037, France
Lyon Cédex 3 , 69437, France
Nantes cedex 1 , 44093, France
Paris Cedex 10 , 75475, France
Paris , 75018, France
Reims Cedex , 51092, France
Frankfurt , 60528, Germany
Hannover , 30625, Germany
Hildesheim , 31134, Germany
Leipzig , 04103, Germany
Lübeck , 23538, Germany
Athens , 11527, Greece
Athens , 14561, Greece
Athens , 16673, Greece
Larissa , 41110, Greece
Thessaloniki , 56429, Greece
Budapest , 1023, Hungary
Budapest , 1036, Hungary
Eger , 3300, Hungary
Nyiregyhaza , 4400, Hungary
Szekesfehervar , 8000, Hungary
Szolnok , 5000, Hungary
Szombathely , 9700, Hungary
Riga , 1001, Latvia
Riga , 1002, Latvia
Riga , 1003, Latvia
Riga , 1005, Latvia
Mexicali Baja California Norte, 21100, Mexico
Guadalajara Jalisco, 44160, Mexico
Guadalajara Jalisco, 44620, Mexico
Guadalajara Jalisco, 44650, Mexico
Ciudad Obregon Sonora, 85000, Mexico
Merida Yucatán, 97133, Mexico
Gdansk , 80-95, Poland
Gdynia , 81-38, Poland
Grodzisk Mazowiecki , 05-82, Poland
Katowice , 40-04, Poland
Lodz , 90-24, Poland
Lodz , 90-43, Poland
Lublin , 20-60, Poland
Poznan , 61-11, Poland
Stalowa Wola , 37-45, Poland
Swidnik , 21-04, Poland
Warszawa , 01-19, Poland
Warszawa , 02-11, Poland
Warszawa , 02-65, Poland
Warszawa , 04-14, Poland
Wroclaw , 50-08, Poland
Wroclaw , 50-36, Poland
Wroclaw , 51-31, Poland
Wroclaw , 53-65, Poland
Chelyabinsk , 45407, Russian Federation
Ekaterinburg , 62007, Russian Federation
Kemerovo , 65009, Russian Federation
Kursk , 30500, Russian Federation
Moscow , 12528, Russian Federation
Petrozavodsk , 18501, Russian Federation
Saint-Petersburg , 19224, Russian Federation
Saratov , 41001, Russian Federation
Smolensk , 21402, Russian Federation
Voronezh , 39406, Russian Federation
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