Psoriatic Arthritis Clinical Trial
— AMVISION-1Official title:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1
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 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
Status | Terminated |
Enrollment | 478 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with = 3 tender and = 3 swollen joints (excluding the distal interphalangeal joints)). - Subjects must have at least 1 psoriatic skin lesion as well as either = 1 erosion on a centrally read radiograph or an elevated CRP. 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Hasselt | |
Belgium | Research Site | Leuven | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Varna | |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Quebec | |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Trois-Rivieres | Quebec |
Canada | Research Site | Waterloo | Ontario |
Czech Republic | Research Site | Brno | |
Czech Republic | Research Site | Brno | |
Czech Republic | Research Site | Ceske Budejovice | |
Czech Republic | Research Site | Ostrava-Trebovice | |
Czech Republic | Research Site | Pardubice | |
Czech Republic | Research Site | Praha 2 | |
Czech Republic | Research Site | Uherske Hradiste | |
Estonia | Research Site | Pärnu | |
Estonia | Research Site | Tallinn | |
France | Research Site | Cahors Cedex | |
France | Research Site | Orleans cedex 2 | |
France | Research Site | Rennes cedex 2 | |
France | Research Site | Saint-Etienne Cedex 2 | |
France | Research Site | Toulouse Cedex 9 | |
France | Research Site | Tours Cedex 1 | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Heraklion | |
Greece | Research Site | Thessaloniki | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Debrecen | |
Hungary | Research Site | Esztergom | |
Hungary | Research Site | Nyiregyhaza | |
Hungary | Research Site | Szekesfehervar | |
Hungary | Research Site | Szolnok | |
Italy | Research Site | Firenze | |
Italy | Research Site | Milano | |
Italy | Research Site | Pavia | |
Italy | Research Site | Roma | |
Italy | Research Site | Roma (RM) | |
Italy | Research Site | Rome | |
Italy | Research Site | Verona | |
Mexico | Research Site | Chihuahua | |
Mexico | Research Site | Ciudad Obregon | Sonora |
Mexico | Research Site | Distrito Federal | |
Mexico | Research Site | Guadalajara | Jalisco |
Mexico | Research Site | Guadalajara | Jalisco |
Mexico | Research Site | Guadalajara | Jalisco |
Mexico | Research Site | Leon | Guanajuato |
Mexico | Research Site | Merida | Yucatán |
Mexico | Research Site | Mexicali | Baja California Norte |
Poland | Research Site | Gdansk | |
Poland | Research Site | Gdynia | |
Poland | Research Site | Katowice | |
Poland | Research Site | Lodz | |
Poland | Research Site | Lodz | |
Poland | Research Site | Lublin | |
Poland | Research Site | Poznan | |
Poland | Research Site | Stalowa Wola | |
Poland | Research Site | Swidnik | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Wroclaw | |
Poland | Research Site | Wroclaw | |
Russian Federation | Research Site | Ekaterinburg | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nizhniy Novgorod | |
Russian Federation | Research Site | Nizhny Novgorod | |
Russian Federation | Research Site | Novosibirsk | |
Russian Federation | Research Site | Saint-Petersburg | |
Russian Federation | Research Site | Saratov | |
Russian Federation | Research Site | Yaroslavl | |
Slovakia | Research Site | Banska Bystrica | |
Slovakia | Research Site | Lucenec | |
Slovakia | Research Site | Rimavska Sobota | |
Slovakia | Research Site | Zilina | |
Spain | Research Site | A Coruña | Galicia |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Cordoba | Andalucía |
Spain | Research Site | Granada | Andalucía |
Spain | Research Site | Hospitalet de Llobregat | Cataluña |
Spain | Research Site | La Vila-Joiosa | Comunidad Valenciana |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Merida | Extremadura |
Spain | Research Site | Sabadell | Cataluña |
Spain | Research Site | Sevilla | Andalucía |
Switzerland | Research Site | Basel | |
Switzerland | Research Site | Geneva 14 | |
Switzerland | Research Site | Lausanne | |
Switzerland | Research Site | Zurich | |
United Kingdom | Research Site | Birmingham | |
United Kingdom | Research Site | Glasgow | |
United Kingdom | Research Site | Hull | |
United Kingdom | Research Site | Leeds | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Manchester | |
United States | Research Site | Asheville | North Carolina |
United States | Research Site | Austin | Texas |
United States | Research Site | Beckley | West Virginia |
United States | Research Site | Bend | Oregon |
United States | Research Site | Bowling Green | Kentucky |
United States | Research Site | Bridgeport | West Virginia |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Clifton | New Jersey |
United States | Research Site | Danville | Virginia |
United States | Research Site | Duncansville | Pennsylvania |
United States | Research Site | Eagan | Minnesota |
United States | Research Site | Frederick | Maryland |
United States | Research Site | Gainesville | Georgia |
United States | Research Site | Glendale | Wisconsin |
United States | Research Site | Great Neck | New York |
United States | Research Site | Hixson | Tennessee |
United States | Research Site | Houston | Texas |
United States | Research Site | Huntsville | Alabama |
United States | Research Site | Jupiter | Florida |
United States | Research Site | Lake Success | New York |
United States | Research Site | Lansing | Michigan |
United States | Research Site | Los Angeles | California |
United States | Research Site | Mather | California |
United States | Research Site | Meridian | Idaho |
United States | Research Site | Murrieta | California |
United States | Research Site | New York | New York |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Palm Desert | California |
United States | Research Site | Peoria | Arizona |
United States | Research Site | Plainview | New York |
United States | Research Site | Portland | Oregon |
United States | Research Site | San Antonio | Texas |
United States | Research Site | Scottsdale | Arizona |
United States | Research Site | Seattle | Washington |
United States | Research Site | Somerset | Kentucky |
United States | Research Site | Springfield | Illinois |
United States | Research Site | Tamarac | Florida |
United States | Research Site | Tampa | Florida |
United States | Research Site | Tuscaloosa | Alabama |
United States | Research Site | Tustin | California |
United States | Research Site | Upland | California |
United States | Research Site | Wheaton | Maryland |
United States | Research Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Greece, Hungary, Italy, Mexico, Poland, Russian Federation, Slovakia, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American College of Rheumatology (ACR) 20 response | To evaluate the efficacy of brodalumab compared to placebo, in subjects with psoriatic arthritis. | 16 weeks | No |
Secondary | Psoriasis Area and Severity Index (PASI) 75 | To evaluate the efficacy of brodalumab compared to placebo at week 16. | 16 Weeks | No |
Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) | To evaluate the efficacy of brodalumab compared to placebo at week 16. | 16 Weeks | No |
Secondary | Psoriasis Symptom Inventory responder definition | To evaluate the efficacy of brodalumab compared to placebo at week 16. | 16 Weeks | No |
Secondary | Van der Heijde modified Total Sharp score (mTSS) | To evaluate the effect of brodalumab compared to placebo at week 24 | 24 Weeks | No |
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