Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
AMVISION-2
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
2 other identifiers
interventional
484
10 countries
103
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2014
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
August 20, 2020
CompletedAugust 20, 2020
August 1, 2020
1.6 years
December 27, 2013
November 2, 2016
August 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
210 mg brodalumab
EXPERIMENTALAdministered via subcutaneous injections.
140 mg brodalumab
EXPERIMENTALAdministered via subcutaneous injection.
Placebo
PLACEBO COMPARATORAdministered via subcutaneous injection until week 24.
Interventions
210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumab administered via subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- -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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Research Site
Peoria, Arizona, 85381, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Cypress, California, 90630, United States
Research Site
Hemet, California, 92543, United States
Research Site
Huntington Beach, California, 92646, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Palm Desert, California, 92260, United States
Research Site
Palo Alto, California, 94304, United States
Research Site
Victorville, California, 92395, United States
Research Site
Sarasota, Florida, 34239, United States
Research Site
St. Petersburg, Florida, 33705, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Tampa, Florida, 33614, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Paducah, Kentucky, 42003, United States
Research Site
Baton Rouge, Louisiana, 70809, United States
Research Site
Wheaton, Maryland, 20902, United States
Research Site
Boston, Massachusetts, 02111, United States
Research Site
Battle Creek, Michigan, 49017, United States
Research Site
Grand Rapids, Michigan, 49546, United States
Research Site
Lansing, Michigan, 48910, United States
Research Site
St Louis, Missouri, 63141, United States
Research Site
Las Vegas, Nevada, 89102, United States
Research Site
Rochester, New York, 14642, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Tulsa, Oklahoma, 74104, United States
Research Site
Dallas, Texas, 75231, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Waco, Texas, 76708, United States
Research Site
Chesapeake, Virginia, 23320, United States
Research Site
Seattle, Washington, 98104, United States
Research Site
Calgary, Alberta, T3A 2N1, Canada
Research Site
Victoria, British Columbia, V8V 3P9, Canada
Research Site
Winnipeg, Manitoba, R3A 1M3, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Research Site
Waterloo, Ontario, N2J 1C4, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Québec, Quebec, G1V 4X7, Canada
Research Site
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Research Site
Bordeaux, 33076, France
Research Site
Le Kremlin-Bicêtre, 94270, France
Research Site
Lille, 59037, France
Research Site
Lyon Cédex 3, 69437, France
Research Site
Nantes, 44093, France
Research Site
Paris, 75018, France
Research Site
Paris, 75475, France
Research Site
Reims, 51092, France
Research Site
Frankfurt, 60528, Germany
Research Site
Hanover, 30625, Germany
Research Site
Hildesheim, 31134, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Lübeck, 23538, Germany
Research Site
Athens, 11527, Greece
Research Site
Athens, 14561, Greece
Research Site
Athens, 16673, Greece
Research Site
Larissa, 41110, Greece
Research Site
Thessaloniki, 56429, Greece
Research Site
Budapest, 1023, Hungary
Research Site
Budapest, 1036, Hungary
Research Site
Eger, 3300, Hungary
Research Site
Nyíregyháza, 4400, Hungary
Research Site
Székesfehérvár, 8000, Hungary
Research Site
Szolnok, 5000, Hungary
Research Site
Szombathely, 9700, Hungary
Research Site
Riga, 1001, Latvia
Research Site
Riga, 1002, Latvia
Research Site
Riga, 1003, Latvia
Research Site
Riga, 1005, Latvia
Research Site
Mexicali, Baja California Norte, 21100, Mexico
Research Site
Guadalajara, Jalisco, 44160, Mexico
Research Site
Guadalajara, Jalisco, 44620, Mexico
Research Site
Guadalajara, Jalisco, 44650, Mexico
Research Site
Ciudad Obregón, Sonora, 85000, Mexico
Research Site
Mérida, Yucatán, 97133, Mexico
Research Site
Gdansk, 80-952, Poland
Research Site
Gdynia, 81-384, Poland
Research Site
Grodzisk Mazowiecki, 05-825, Poland
Research Site
Katowice, 40-040, Poland
Research Site
Lodz, 90-242, Poland
Research Site
Lodz, 90-436, Poland
Research Site
Lublin, 20-607, Poland
Research Site
Poznan, 61-113, Poland
Research Site
Stalowa Wola, 37-450, Poland
Research Site
Świdnik, 21-040, Poland
Research Site
Warsaw, 01-192, Poland
Research Site
Warsaw, 02-118, Poland
Research Site
Warsaw, 02-653, Poland
Research Site
Warsaw, 04-141, Poland
Research Site
Wroclaw, 50-088, Poland
Research Site
Wroclaw, 50-368, Poland
Research Site
Wroclaw, 51-318, Poland
Research Site
Wroclaw, 53-658, Poland
Research Site
Chelyabinsk, 454076, Russia
Research Site
Kemerovo, 650099, Russia
Research Site
Kursk, 305007, Russia
Research Site
Moscow, 125284, Russia
Research Site
Petrozavodsk, 185019, Russia
Research Site
Saint Petersburg, 192242, Russia
Research Site
Saratov, 410012, Russia
Research Site
Smolensk, 214025, Russia
Research Site
Voronezh, 394066, Russia
Research Site
Yekaterinburg, 620076, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2013
First Posted
December 31, 2013
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
August 20, 2020
Results First Posted
August 20, 2020
Record last verified: 2020-08