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

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ClinicalTrials.gov Identifier: NCT02024646
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 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 and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2
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

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.




Primary Outcome Measures :
  1. ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 [ Time Frame: Baseline and 16 Weeks ]
    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.



Information from the National Library of Medicine

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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:

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


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): NCT02024646


Locations
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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT02024646    
Other Study ID Numbers: 20110144
2013-003553-16 ( EudraCT Number )
First Posted: December 31, 2013    Key Record Dates
Results First Posted: August 20, 2020
Last Update Posted: August 20, 2020
Last Verified: August 2020
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