Psoriatic Arthritis Clinical Trial
— AMVISION-2Official title:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
| Verified date | August 2020 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 484 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Quebec | |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Trois-Rivieres | Quebec |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | Winnipeg | Manitoba |
| France | Research Site | Bordeaux Cedex | |
| France | Research Site | Le Kremlin Bicetre | |
| France | Research Site | Lille cedex | |
| France | Research Site | Lyon Cédex 3 | |
| France | Research Site | Nantes cedex 1 | |
| France | Research Site | Paris | |
| France | Research Site | Paris Cedex 10 | |
| France | Research Site | Reims Cedex | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Hildesheim | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Lübeck | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Nyiregyhaza | |
| Hungary | Research Site | Szekesfehervar | |
| Hungary | Research Site | Szolnok | |
| Hungary | Research Site | Szombathely | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Riga | |
| Mexico | Research Site | Ciudad Obregon | Sonora |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Merida | Yucatán |
| Mexico | Research Site | Mexicali | Baja California Norte |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Grodzisk Mazowiecki | |
| 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 | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Chelyabinsk | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Kursk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Petrozavodsk | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | Smolensk | |
| Russian Federation | Research Site | Voronezh | |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Battle Creek | Michigan |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Chesapeake | Virginia |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cypress | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Grand Rapids | Michigan |
| United States | Research Site | Hemet | California |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lansing | Michigan |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Paducah | Kentucky |
| United States | Research Site | Palm Desert | California |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Peoria | Arizona |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Victorville | California |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Canada, France, Germany, Greece, Hungary, Latvia, Mexico, Poland, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success. | Baseline and 16 Weeks |
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