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

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ClinicalTrials.gov Identifier: NCT02029495
Recruitment Status : Terminated (Sponsor Decision)
First Posted : January 8, 2014
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Brodalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 210 mg brodalumab
Administered via subcutaneous injections
 Drug: 210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection
Other Name: AMG 827
Experimental: 140 mg brodalumab
Administered via subcutaneous injection
 Drug: 140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection
Other Name: AMG 827
Placebo Comparator: Placebo
Administered via subcutaneous injection until week 24.
 Drug: Placebo
Placebo administered via subcutaneous injection until week 24.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029495


Locations
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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02029495    
Other Study ID Numbers: 20090406
2013-003554-25 ( EudraCT Number )
First Posted: January 8, 2014    Key Record Dates
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Bausch Health Americas, Inc.:
Psoriatic Arthritis
Brodalumab
AMG 827
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
 Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs