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
|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 :||484 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 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|
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.
- 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.
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