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Sponsor Decision

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-1)

ClinicalTrials.gov ID NCT02029495
Sponsor Bausch Health Americas, Inc.
Information provided by Bausch Health Americas, Inc. (Responsible Party)
Last Update Posted 2017-05-19
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Study Overview

Brief Summary
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.
Detailed Description
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.
Official 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
Conditions
Psoriatic Arthritis
Intervention / Treatment
  • Drug: 210 mg brodalumab
  • Drug: 140 mg brodalumab
  • Drug: Placebo
  • Drug: 210 mg brodalumab
  • Drug: 140 mg brodalumab
  • Drug: Placebo
Other Study ID Numbers
  • 20090406
  • 2013-003554-25 ( EudraCT Number )
    2013-003554-25 ( EudraCT Number )
Study Start
2014-03
Primary Completion (Actual)
2015-10
Study Completion (Actual)
2015-10
Enrollment (Actual)
478
Study Type
Interventional
Phase
Phase 3

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 152 locations
United States
Alabama Locations
Huntsville, Alabama, United States, 35801

Research Site
Tuscaloosa, Alabama, United States, 35406

Research Site
Arizona Locations
Peoria, Arizona, United States, 85381

Research Site
Scottsdale, Arizona, United States, 85258

Research Site
California Locations
Los Angeles, California, United States, 90095

Research Site
Mather, California, United States, 95655

Research Site
Murrieta, California, United States, 92563

Research Site
Palm Desert, California, United States, 92260

Research Site
Tustin, California, United States, 92780

Research Site
Upland, California, United States, 91786

Research Site
Florida Locations
Jupiter, Florida, United States, 33458

Research Site
Tamarac, Florida, United States, 33321

Research Site
Tampa, Florida, United States, 33613

Research Site
Georgia Locations
Gainesville, Georgia, United States, 30501

Research Site
Idaho Locations
Meridian, Idaho, United States, 83642

Research Site
Illinois Locations
Springfield, Illinois, United States, 62703

Research Site
Kentucky Locations
Bowling Green, Kentucky, United States, 42101

Research Site
Somerset, Kentucky, United States, 42503

Research Site
Maryland Locations
Frederick, Maryland, United States, 21702

Research Site
Wheaton, Maryland, United States, 20902

Research Site
Massachusetts Locations
Worcester, Massachusetts, United States, 01605

Research Site
Michigan Locations
Lansing, Michigan, United States, 48910

Research Site
Minnesota Locations
Eagan, Minnesota, United States, 55121

Research Site
Nebraska Locations
Omaha, Nebraska, United States, 68114

Research Site
New Jersey Locations
Clifton, New Jersey, United States, 07012

Research Site
New York Locations
Great Neck, New York, United States, 11021

Research Site
Lake Success, New York, United States, 11042

Research Site
New York, New York, United States, 10016

Research Site
Plainview, New York, United States, 11803

Research Site
North Carolina Locations
Asheville, North Carolina, United States, 28803

Research Site
Oregon Locations
Bend, Oregon, United States, 97701

Research Site
Portland, Oregon, United States, 97239

Research Site
Pennsylvania Locations
Duncansville, Pennsylvania, United States, 16635

Research Site
South Carolina Locations
Charleston, South Carolina, United States, 29406

Research Site
Tennessee Locations
Hixson, Tennessee, United States, 37343

Research Site
Texas Locations
Austin, Texas, United States, 78731

Research Site
Houston, Texas, United States, 77074

Research Site
San Antonio, Texas, United States, 78232

Research Site
Virginia Locations
Danville, Virginia, United States, 24541

Research Site
Washington Locations
Seattle, Washington, United States, 98104

Research Site
West Virginia Locations
Beckley, West Virginia, United States, 25801

Research Site
Bridgeport, West Virginia, United States, 26330

Research Site
Wisconsin Locations
Glendale, Wisconsin, United States, 53217

Research Site
Belgium
Hasselt, Belgium, 3500

Research Site
Leuven, Belgium, 3000

Research Site
Bulgaria
Plovdiv, Bulgaria, 4002

Research Site
Plovdiv, Bulgaria, 4003

Research Site
Sofia, Bulgaria, 1612

Research Site
Sofia, Bulgaria, 1709

Research Site
Varna, Bulgaria, 9010

Research Site
Canada
Quebec, Canada, G1V 3M7

Research Site
Alberta Locations
Calgary, Alberta, Canada, T2G 1B1

Research Site
Calgary, Alberta, Canada, T3A 2N1

Research Site
Ontario Locations
Toronto, Ontario, Canada, M5T 2S8

Research Site
Waterloo, Ontario, Canada, N2J 1C4

Research Site
Quebec Locations
Trois-Rivieres, Quebec, Canada, G8Z 1Y2

Research Site
Czech Republic
Brno, Czech Republic, 611 41

Research Site
Brno, Czech Republic, 638 00

Research Site
Ceske Budejovice, Czech Republic, 370 01

Research Site
Ostrava-Trebovice, Czech Republic, 722 00

Research Site
Pardubice, Czech Republic, 530 02

Research Site
Praha 2, Czech Republic, 128 50

Research Site
Uherske Hradiste, Czech Republic, 686 01

Research Site
Estonia
Pärnu, Estonia, 80010

Research Site
Tallinn, Estonia, 10117

Research Site
France
Cahors Cedex, France, 46005

Research Site
Orleans cedex 2, France, 45067

Research Site
Rennes cedex 2, France, 35203

Research Site
Saint-Etienne Cedex 2, France, 42055

Research Site
Toulouse Cedex 9, France, 31059

Research Site
Tours Cedex 1, France, 37044

Research Site
Greece
Athens, Greece, 11527

Research Site
Athens, Greece, 12462

Research Site
Athens, Greece, 16121

Research Site
Athens, Greece, 16673

Research Site
Heraklion, Greece, 71110

Research Site
Thessaloniki, Greece, 56429

Research Site
Hungary
Budapest, Hungary, 1036

Research Site
Budapest, Hungary, 1062

Research Site
Debrecen, Hungary, 4032

Research Site
Esztergom, Hungary, 2500

Research Site
Nyiregyhaza, Hungary, 4400

Research Site
Szekesfehervar, Hungary, 8000

Research Site
Szolnok, Hungary, 5000

Research Site
Italy
Firenze, Italy, 50134

Research Site
Milano, Italy, 20122

Research Site
Pavia, Italy, 27100

Research Site
Roma (RM), Italy, 00133

Research Site
Roma, Italy, 00152

Research Site
Rome, Italy, 00144

Research Site
Verona, Italy, 37126

Research Site
Mexico
Chihuahua, Mexico, 31000

Research Site
Distrito Federal, Mexico, 03100

Research Site
Baja California Norte Locations
Mexicali, Baja California Norte, Mexico, 21100

Research Site
Guanajuato Locations
Leon, Guanajuato, Mexico, 37520

Research Site
Jalisco Locations
Guadalajara, Jalisco, Mexico, 44160

Research Site
Guadalajara, Jalisco, Mexico, 44620

Research Site
Guadalajara, Jalisco, Mexico, 44650

Research Site
Sonora Locations
Ciudad Obregon, Sonora, Mexico, 85000

Research Site
Yucatán Locations
Merida, Yucatán, Mexico, 97133

Research Site
Poland
Gdansk, Poland, 80-952

Research Site
Gdynia, Poland, 81-384

Research Site
Katowice, Poland, 40-040

Research Site
Lodz, Poland, 90-242

Research Site
Lodz, Poland, 90-436

Research Site
Lublin, Poland, 20-607

Research Site
Poznan, Poland, 61-113

Research Site
Stalowa Wola, Poland, 37-450

Research Site
Swidnik, Poland, 21-040

Research Site
Warszawa, Poland, 01-192

Research Site
Warszawa, Poland, 02-118

Research Site
Warszawa, Poland, 02-653

Research Site
Warszawa, Poland, 04-141

Research Site
Wroclaw, Poland, 50-088

Research Site
Wroclaw, Poland, 50-368

Research Site
Wroclaw, Poland, 51-318

Research Site
Russian Federation
Ekaterinburg, Russian Federation, 620102

Research Site
Moscow, Russian Federation, 115522

Research Site
Moscow, Russian Federation, 127473

Research Site
Nizhniy Novgorod, Russian Federation, 603126

Research Site
Nizhny Novgorod, Russian Federation, 603005

Research Site
Novosibirsk, Russian Federation, 630099

Research Site
Saint-Petersburg, Russian Federation, 190068

Research Site
Saratov, Russian Federation, 410012

Research Site
Yaroslavl, Russian Federation, 150062

Research Site
Slovakia
Banska Bystrica, Slovakia, 974 05

Research Site
Lucenec, Slovakia, 984 01

Research Site
Rimavska Sobota, Slovakia, 979 01

Research Site
Zilina, Slovakia, 01001

Research Site
Spain
Madrid, Spain, 28007

Research Site
Madrid, Spain, 28031

Research Site
Andalucía Locations
Cordoba, Andalucía, Spain, 14004

Research Site
Granada, Andalucía, Spain, 18014

Research Site
Sevilla, Andalucía, Spain, 41009

Research Site
Cataluña Locations
Barcelona, Cataluña, Spain, 08036

Research Site
Barcelona, Cataluña, Spain, 08041

Research Site
Hospitalet de Llobregat, Cataluña, Spain, 08907

Research Site
Sabadell, Cataluña, Spain, 08208

Research Site
Comunidad Valenciana Locations
La Vila-Joiosa, Comunidad Valenciana, Spain, 03570

Research Site
Extremadura Locations
Merida, Extremadura, Spain, 06800

Research Site
Galicia Locations
A Coruña, Galicia, Spain, 15006

Research Site
Switzerland
Basel, Switzerland, 4031

Research Site
Geneva 14, Switzerland, 1211

Research Site
Lausanne, Switzerland, 1011

Research Site
Zurich, Switzerland, 8091

Research Site
United Kingdom
Birmingham, United Kingdom, B15 2TH

Research Site
Glasgow, United Kingdom, G31 2ER

Research Site
Hull, United Kingdom, HU3 2JZ

Research Site
Leeds, United Kingdom, LS7 4SA

Research Site
London, United Kingdom, E11 1NR

Research Site
London, United Kingdom, SE1 9RT

Research Site
Manchester, United Kingdom, M13 9WL

Research Site
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: 210 mg brodalumab
Administered via subcutaneous injections
Intervention/Treatment Drug: 210 mg brodalumab
  • 210 mg brodalumab administered via subcutaneous injection

  • Other Names:
    • AMG 827
Participant Group/Arm Experimental: 140 mg brodalumab
Administered via subcutaneous injection
Intervention/Treatment Drug: 140 mg brodalumab
  • 140 mg brodalumab administered via subcutaneous injection

  • Other Names:
    • AMG 827
Participant Group/Arm Placebo Comparator: Placebo
Administered via subcutaneous injection until week 24.
Intervention/Treatment Drug: Placebo
  • Placebo administered via subcutaneous injection until week 24.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
American College of Rheumatology (ACR) 20 ResponseAn ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).16 weeks
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Psoriasis Area and Severity Index (PASI)75PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Bausch Health Americas, Inc.
Investigators
  • Study Director:MD,Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2014-01-06
First Submitted that Met QC Criteria
2014-01-06
First Posted (Estimated)
2014-01-08
Results Reporting Dates
Results First Submitted
2016-11-08
Results First Submitted that Met QC Criteria
2017-04-07
Results First Posted
2017-05-19
Certification/Extension Dates
Certification/Extension First Submitted
2016-03-14
Certification/Extension First Submitted that Met QC Criteria
2016-03-14
Certification/Extension First Posted (Estimated)
2016-04-13
Study Record Updates
Last Update Submitted that met QC Criteria
2017-04-07
Last Update Posted
2017-05-19
Last Verified
2017-04

More Information

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Keywords Provided by Bausch Health Americas, Inc.
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
Yes