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Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-2)

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
210 mg brodalumab
140 mg brodalumab
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Brodalumab, AMG 827

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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

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.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2013
Last Updated
August 8, 2020
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02024646
Brief Title
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Acronym
AMVISION-2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
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. 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.

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
484 (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
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
Description
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.
Time Frame
Baseline and 16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Research Site
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Research Site
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
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Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
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United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
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United States
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Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
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United States
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Research Site
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
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United States
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Research Site
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
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United States
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Research Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
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United States
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Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
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United States
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Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
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United States
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Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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United States
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Research Site
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Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
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United States
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Research Site
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Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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United States
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Research Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
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United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
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United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
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United States
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Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
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Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
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Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
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Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
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
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Research Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Research Site
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Lyon Cédex 3
ZIP/Postal Code
69437
Country
France
Facility Name
Research Site
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Research Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
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Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23538
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Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
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Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14561
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Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
16673
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Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
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Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Eger
ZIP/Postal Code
3300
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
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1003
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1005
Country
Latvia
Facility Name
Research Site
City
Mexicali
State/Province
Baja California Norte
ZIP/Postal Code
21100
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
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
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
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
Wroclaw
ZIP/Postal Code
53-658
Country
Poland
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620076
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Research Site
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis

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