The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.
To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Efficacy
Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52
Time frame: 52 weeks
Safety of Alefacept Using CD4 Counts
Number of participants experiencing CD4 cell counts below 250/uL
Time frame: 52 weeks
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