Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis|
- To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of Patients Who Were Both Intralesional and Intramuscular Responders. [ Time Frame: 12 weeks after intramuscular injection of alefacept. ] [ Designated as safety issue: No ]Patients were first injected with alefacept into a single "target" plaque. Those who had improvement in the plaque from baseline were deemed "intralesional responders". All the patients then were injected with alefacept intramuscularly. The patients who had a 70% or greater improvement in their psoriasis severity score (includes assessment of entire body) were systemic responders to alefacept. The number of patients who were both intralesional and systemic responders was measured.
|Study Start Date:||September 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Investigational intervention without random assignment
Drug: Intralesional Alefacept
Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.
Other Name: Amevive
See Brief Summary
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678470
|United States, California|
|UCSF Psoriasis and Skin Treatment Center|
|San Francisco, California, United States, 94118|
|Principal Investigator:||John Koo, MD||UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco|