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

April 7, 2017 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

478

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • 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
      • Calgary, Alberta, Canada, T2G 1B1
        • Research Site
      • Calgary, Alberta, Canada, T3A 2N1
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
    • Quebec
      • 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, 16673
        • Research Site
      • Athens, Greece, 12462
        • Research Site
      • Athens, Greece, 16121
        • Research Site
      • Heraklion, Greece, 71110
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
  • Hungary
      • Budapest, Hungary, 1062
        • Research Site
      • Budapest, Hungary, 1036
        • 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, Italy, 00152
        • Research Site
      • Roma (RM), Italy, 00133
        • 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
      • Mexicali, Baja California Norte, Mexico, 21100
        • Research Site
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37520
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44160
        • Research Site
      • Guadalajara, Jalisco, Mexico, 44620
        • Research Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Research Site
    • Yucatán
      • 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, 90-436
        • Research Site
      • Lodz, Poland, 90-242
        • 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, 04-141
        • Research Site
      • Warszawa, Poland, 02-118
        • Research Site
      • Warszawa, Poland, 02-653
        • 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, 28031
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
      • Granada, Andalucía, Spain, 18014
        • Research Site
      • Sevilla, Andalucía, Spain, 41009
        • Research Site
    • Cataluña
      • 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
      • La Vila-Joiosa, Comunidad Valenciana, Spain, 03570
        • Research Site
    • Extremadura
      • Merida, Extremadura, Spain, 06800
        • Research Site
    • Galicia
      • 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, SE1 9RT
        • Research Site
      • London, United Kingdom, E11 1NR
        • Research Site
      • Manchester, United Kingdom, M13 9WL
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Tuscaloosa, Alabama, United States, 35406
        • Research Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • 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
      • Jupiter, Florida, United States, 33458
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Research Site
      • Tampa, Florida, United States, 33613
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Research Site
      • Somerset, Kentucky, United States, 42503
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Site
      • Wheaton, Maryland, United States, 20902
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Research Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Research Site
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New Jersey
      • Clifton, New Jersey, United States, 07012
        • Research Site
    • New York
      • 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
      • Asheville, North Carolina, United States, 28803
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Research Site
    • Tennessee
      • Hixson, Tennessee, United States, 37343
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • San Antonio, Texas, United States, 78232
        • Research Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Research Site
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Research Site
      • Bridgeport, West Virginia, United States, 26330
        • Research Site
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Research Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 210 mg brodalumab
Administered via subcutaneous injections
Drug: 210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection
Other Names:
  • AMG 827
EXPERIMENTAL: 140 mg brodalumab
Administered via subcutaneous injection
Drug: 140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection
Other Names:
  • AMG 827
PLACEBO_COMPARATOR: Placebo
Administered via subcutaneous injection until week 24.
Drug: Placebo
Placebo administered via subcutaneous injection until week 24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology (ACR) 20 Response
Time Frame: 16 weeks
An 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)75
Time Frame: 16 Weeks
PASI75 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (ESTIMATE)

January 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090406
  • 2013-003554-25 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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