Psoriatic ArthritisPhase 3AMVISION-1NCT02029495

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 152 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriatic Arthritis
What is being tested?: 210 mg brodalumab and 140 mg brodalumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 478 participants
Where: 152 sitesin 17 countries
Study dates: Mar 2014to Oct 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

152 sites in 17 countries.

Country

City, postcode or hospital

152 sites in 17 countries

United States43 sites

Research Site
Asheville, North Carolina, 28803
Research Site
Austin, Texas, 78731
Research Site
Beckley, West Virginia, 25801
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Bend, Oregon, 97701
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Bowling Green, Kentucky, 42101
Research Site
Bridgeport, West Virginia, 26330
Research Site
Charleston, South Carolina, 29406
Research Site
Clifton, New Jersey, 07012
Research Site
Danville, Virginia, 24541
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Eagan, Minnesota, 55121
Research Site
Frederick, Maryland, 21702
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Gainesville, Georgia, 30501
Research Site
Glendale, Wisconsin, 53217
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Great Neck, New York, 11021
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Hixson, Tennessee, 37343
Research Site
Houston, Texas, 77074
Research Site
Huntsville, Alabama, 35801
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Jupiter, Florida, 33458
Research Site
Lake Success, New York, 11042
Research Site
Lansing, Michigan, 48910
Research Site
Los Angeles, California, 90095
Research Site
Mather, California, 95655
Research Site
Meridian, Idaho, 83642
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Murrieta, California, 92563
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New York, New York, 10016
Research Site
Omaha, Nebraska, 68114
Research Site
Palm Desert, California, 92260
Research Site
Peoria, Arizona, 85381
Research Site
Plainview, New York, 11803
Research Site
Portland, Oregon, 97239
Research Site
San Antonio, Texas, 78232
Research Site
Scottsdale, Arizona, 85258
Research Site
Seattle, Washington, 98104
Research Site
Somerset, Kentucky, 42503
Research Site
Springfield, Illinois, 62703
Research Site
Tamarac, Florida, 33321
Research Site
Tampa, Florida, 33613
Research Site
Tuscaloosa, Alabama, 35406
Research Site
Tustin, California, 92780
Research Site
Upland, California, 91786
Research Site
Wheaton, Maryland, 20902
Research Site
Worcester, Massachusetts, 01605

Other trials in United States

Poland16 sites

Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-384
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Katowice, 40-040
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Lodz, 90-242
Research Site
Lodz, 90-436
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Lublin, 20-607
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Poznan, 61-113
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Stalowa Wola, 37-450
Research Site
Świdnik, 21-040
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Warsaw, 01-192
Research Site
Warsaw, 02-118
Research Site
Warsaw, 02-653
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 50-088
Research Site
Wroclaw, 50-368
Research Site
Wroclaw, 51-318

Other trials in Poland

Spain12 sites

Research Site
A Coruña, Galicia, 15006
Research Site
Barcelona, Catalonia, 08036
Research Site
Barcelona, Catalonia, 08041
Research Site
Córdoba, Andalusia, 14004
Research Site
Granada, Andalusia, 18014
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
Madrid, Madrid, 28007
Research Site
Madrid, Madrid, 28031
Research Site
Mérida, Extremadura, 06800
Research Site
Sabadell, Catalonia, 08208
Research Site
Seville, Andalusia, 41009
Research Site
Villajoyosa, Valencia, 03570

Other trials in Spain

Mexico9 sites

Research Site
Chihuahua City, Chihuahua, 31000
Research Site
Ciudad Obregón, Sonora, 85000
Research Site
Distrito Federal, Mexico, 03100
Research Site
Guadalajara, Jalisco, 44160
Research Site
Guadalajara, Jalisco, 44620
Research Site
Guadalajara, Jalisco, 44650
Research Site
León, Guanajuato, 37520
Research Site
Mérida, Yucatán, 97133
Research Site
Mexicali, Baja California Norte, 21100

Other trials in Mexico

Russia9 sites

Research Site
Moscow, 115522
Research Site
Moscow, 127473
Research Site
Nizhny Novgorod, 603005
Research Site
Nizhny Novgorod, 603126
Research Site
Novosibirsk, 630099
Research Site
Saint Petersburg, 190068
Research Site
Saratov, 410012
Research Site
Yaroslavl, 150062
Research Site
Yekaterinburg, 620102

Other trials in Russia

Czechia7 sites

Research Site
Brno, 611 41
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Brno, 638 00
Research Site
České Budějovice, 370 01
Research Site
Ostrava-Trebovice, 722 00
Research Site
Pardubice, 530 02
Research Site
Prague, 128 50
Research Site
Uherské Hradiště, 686 01

Other trials in Czechia

Hungary7 sites

Research Site
Budapest, 1036
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Budapest, 1062
Research Site
Debrecen, 4032
Research Site
Esztergom, 2500
Research Site
Nyíregyháza, 4400
Research Site
Székesfehérvár, 8000
Research Site
Szolnok, 5000

Other trials in Hungary

Italy7 sites

Research Site
Florence, 50134
Research Site
Milan, 20122
Research Site
Pavia, 27100
Research Site
Roma, 00152
Research Site
Roma (RM), 00133
Research Site
Rome, 00144
Research Site
Verona, 37126

Other trials in Italy

United Kingdom7 sites

Research Site
Birmingham, B15 2TH
Research Site
Glasgow, G31 2ER
Research Site
Hull, HU3 2JZ
Research Site
Leeds, LS7 4SA
Research Site
London, E11 1NR
Research Site
London, SE1 9RT
Research Site
Manchester, M13 9WL

Other trials in United Kingdom

Canada6 sites

Research Site
Calgary, Alberta, T2G 1B1
Research Site
Calgary, Alberta, T3A 2N1
Research Site
Québec, Quebec, G1V 3M7
Research Site
Toronto, Ontario, M5T 2S8
Research Site
Trois-Rivières, Quebec, G8Z 1Y2
Research Site
Waterloo, Ontario, N2J 1C4

Other trials in Canada

France6 sites

Research Site
Cahors, 46005
Research Site
Orléans, 45067
Research Site
Rennes, 35203
Research Site
Saint-Etienne, 42055
Research Site
Toulouse, 31059
Research Site
Tours, 37044

Other trials in France

Greece6 sites

Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 16121
Research Site
Athens, 16673
Research Site
Heraklion, 71110
Research Site
Thessaloniki, 56429

Other trials in Greece

Bulgaria5 sites

Research Site
Plovdiv, 4002
Research Site
Plovdiv, 4003
Research Site
Sofia, 1612
Research Site
Sofia, 1709
Research Site
Varna, 9010

Other trials in Bulgaria

Slovakia4 sites

Research Site
Banská Bystrica, 974 05
Research Site
Lučenec, 984 01
Research Site
Rimavská Sobota, 979 01
Research Site
Žilina, 01001

Other trials in Slovakia

Switzerland4 sites

Research Site
Basel, 4031
Research Site
Geneva, 1211
Research Site
Lausanne, 1011
Research Site
Zurich, 8091

Other trials in Switzerland

Belgium2 sites

Research Site
Hasselt, 3500
Research Site
Leuven, 3000

Other trials in Belgium

Estonia2 sites

Research Site
Pärnu, 80010
Research Site
Tallinn, 10117

Other trials in Estonia

About this study

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

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Read the 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.

Conditions: Psoriatic Arthritis
Being tested: 210 mg brodalumab, 140 mg brodalumab, Placebo
Keywords: Psoriatic Arthritis, Brodalumab, AMG 827
Medical subject headings: Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

210 mg brodalumabDrug
Also called AMG 827
210 mg brodalumab administered via subcutaneous injection
140 mg brodalumabDrug
Also called AMG 827
140 mg brodalumab administered via subcutaneous injection
PlaceboDrug
Placebo administered via subcutaneous injection until week 24.

Study groups in NCT02029495
Study group	Role	What they receive
210 mg brodalumab	Experimental	Administered via subcutaneous injections Receives: Drug: 210 mg brodalumab
140 mg brodalumab	Experimental	Administered via subcutaneous injection Receives: Drug: 140 mg brodalumab
Placebo	Placebo comparator	Administered via subcutaneous injection until week 24. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 16 weeks

Secondary outcomes (1)

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.
Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Oct 2015

First posted8 Jan 2014 (estimated)
Study startMar 2014
Primary completionOct 2015
Study completionOct 2015

Why it stopped: Sponsor Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02029495
Sponsor's protocol ID: 20090406
Other IDs: 2013-003554-25
Acronym: AMVISION-1
Status last verified: Apr 2017
First submitted: 6 Jan 2014
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

All Psoriatic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02029495
Acronym / sponsor ID: AMVISION-1 / 20090406
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis, Brodalumab, AMG 827
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor Decision
Enrolment: 478 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 8 Jan 2014 (estimated)
Results: Posted 19 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
210 mg brodalumab	Experimental	Drug: 210 mg brodalumabAdministered via subcutaneous injections
140 mg brodalumab	Experimental	Drug: 140 mg brodalumabAdministered via subcutaneous injection
Placebo	Placebo comparator	Drug: PlaceboAdministered via subcutaneous injection until week 24.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
210 mg brodalumabAlso: AMG 827210 mg brodalumab administered via subcutaneous injection	Drug	210 mg brodalumab
140 mg brodalumabAlso: AMG 827140 mg brodalumab administered via subcutaneous injection	Drug	140 mg brodalumab
PlaceboPlacebo administered via subcutaneous injection until week 24.	Drug	Placebo

Primary outcome

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).

1 secondary outcome

Psoriasis Area and Severity Index (PASI)75
Time frame: 16 Weeks

Results and safety

Results posted to the registry on 19 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
210 mg Brodalumab	159	158
140 mg Brodalumab	158	158
Placebo	161	159

Primary outcome: American College of Rheumatology (ACR) 20 Response

Time frame: 16 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	210 mg Brodalumab n = 121	140 mg Brodalumab n = 118	Placebo n = 122
Value	0 (0 to 0)	21.8 (10.6 to 33.1)	36.5 (22.8 to 45.3)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
210 mg Brodalumab	10 of 158 (6.3%)	84 of 158 (53.2%)	Not reported
140 mg Brodalumab	5 of 158 (3.2%)	79 of 158 (50%)	Not reported
Placebo	4 of 159 (2.5%)	71 of 159 (44.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Psoriatic Arthritis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

152 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriatic Arthritis, run by Bausch Health Americas, Inc. at 152 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Poland, Spain, Mexico, Russia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology (ACR) 20 Response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02029495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.