Back to resultsStudy of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-1)
Primary Purpose
Psoriatic Arthritis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
210 mg brodalumab
140 mg brodalumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Brodalumab, AMG 827
Eligibility Criteria
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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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
210 mg brodalumab
140 mg brodalumab
Placebo
Arm Description
Administered via subcutaneous injections
Administered via subcutaneous injection
Administered via subcutaneous injection until week 24.
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 20 Response
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).
Secondary Outcome Measures
Psoriasis Area and Severity Index (PASI)75
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.
Full Information
NCT ID
NCT02029495
First Posted
January 6, 2014
Last Updated
April 7, 2017
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02029495
Brief Title
Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
Acronym
AMVISION-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, Brodalumab, AMG 827
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
478 (Actual)
8. Arms, Groups, and Interventions
Arm Title
210 mg brodalumab
Arm Type
Experimental
Arm Description
Administered via subcutaneous injections
Arm Title
140 mg brodalumab
Arm Type
Experimental
Arm Description
Administered via subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered via subcutaneous injection until week 24.
Intervention Type
Drug
Intervention Name(s)
210 mg brodalumab
Other Intervention Name(s)
AMG 827
Intervention Description
210 mg brodalumab administered via subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
140 mg brodalumab
Other Intervention Name(s)
AMG 827
Intervention Description
140 mg brodalumab administered via subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered via subcutaneous injection until week 24.
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 Response
Description
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).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI)75
Description
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.
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
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Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
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Research Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
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Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
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United States
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Research Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
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Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
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Research Site
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Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
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Research Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
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Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
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Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
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United States
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Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
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United States
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Research Site
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Springfield
State/Province
Illinois
ZIP/Postal Code
62703
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United States
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Research Site
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Bowling Green
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Kentucky
ZIP/Postal Code
42101
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United States
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Research Site
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Somerset
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Kentucky
ZIP/Postal Code
42503
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United States
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Research Site
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Frederick
State/Province
Maryland
ZIP/Postal Code
21702
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United States
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Research Site
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Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
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United States
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Research Site
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Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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United States
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Lansing
State/Province
Michigan
ZIP/Postal Code
48910
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United States
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Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
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United States
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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United States
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Clifton
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New Jersey
ZIP/Postal Code
07012
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United States
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Great Neck
State/Province
New York
ZIP/Postal Code
11021
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United States
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Research Site
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Lake Success
State/Province
New York
ZIP/Postal Code
11042
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United States
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Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
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United States
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Research Site
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
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United States
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Research Site
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Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
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United States
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Bend
State/Province
Oregon
ZIP/Postal Code
97701
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United States
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Portland
State/Province
Oregon
ZIP/Postal Code
97239
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United States
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Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
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United States
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Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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United States
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Hixson
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Tennessee
ZIP/Postal Code
37343
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United States
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Austin
State/Province
Texas
ZIP/Postal Code
78731
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United States
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Houston
State/Province
Texas
ZIP/Postal Code
77074
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United States
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Research Site
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San Antonio
State/Province
Texas
ZIP/Postal Code
78232
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United States
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City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
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United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
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United States
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Research Site
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
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United States
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Research Site
City
Bridgeport
State/Province
West Virginia
ZIP/Postal Code
26330
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United States
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Research Site
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
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Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
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Belgium
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Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
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Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
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Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
611 41
Country
Czech Republic
Facility Name
Research Site
City
Brno
ZIP/Postal Code
638 00
Country
Czech Republic
Facility Name
Research Site
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czech Republic
Facility Name
Research Site
City
Ostrava-Trebovice
ZIP/Postal Code
722 00
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
Facility Name
Research Site
City
Pärnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Research Site
City
Cahors Cedex
ZIP/Postal Code
46005
Country
France
Facility Name
Research Site
City
Orleans cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Research Site
City
Rennes cedex 2
ZIP/Postal Code
35203
Country
France
Facility Name
Research Site
City
Saint-Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Tours Cedex 1
ZIP/Postal Code
37044
Country
France
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
16673
Country
Greece
Facility Name
Research Site
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Roma (RM)
ZIP/Postal Code
00133
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Mexicali
State/Province
Baja California Norte
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Research Site
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37520
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Research Site
City
Ciudad Obregon
State/Province
Sonora
ZIP/Postal Code
85000
Country
Mexico
Facility Name
Research Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97133
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Research Site
City
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Research Site
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Research Site
City
Banska Bystrica
ZIP/Postal Code
974 05
Country
Slovakia
Facility Name
Research Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Research Site
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Sabadell
State/Province
Cataluña
ZIP/Postal Code
08208
Country
Spain
Facility Name
Research Site
City
La Vila-Joiosa
State/Province
Comunidad Valenciana
ZIP/Postal Code
03570
Country
Spain
Facility Name
Research Site
City
Merida
State/Province
Extremadura
ZIP/Postal Code
06800
Country
Spain
Facility Name
Research Site
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Research Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Research Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
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