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
|Condition or disease||Intervention/treatment||Phase|
|Psoriatic Arthritis||Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||478 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||October 2015|
|Study Completion Date :||October 2015|
U.S. FDA Resources
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.
Placebo administered via subcutaneous injection until week 24.
- 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).
- 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.
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
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