Chronic Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.
Interventions
DRUGAlefacept
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent. * At least 16 years of age. * Diagnosed with chronic plaque psoriasis and require systemic therapy. * CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Exclusion criteria
* Unstable erthrodermic or pustular psoriasis. * Diagnosis of guttate psoriasis. * Serious local infection or systemic infection within 3 months prior to first dose of alefacept. * Positive for HIV antibody. * Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded. * Evidence of active tuberculosis. * Current treatment for active tuberculosis or tuberculosis prophylaxis. * Female patients unwilling to practice effective contraception as defined by the investigator. * Female patients who are pregnant or breast-feeding. * Current enrollment in any other investigational drug study. * Previous participation in this study or previous alefacept studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients who achieve a Physician Global Assessment (PGA) of almost clear or clear over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary). | — |
Countries
Austria, Canada, Denmark, France, Germany, Netherlands, Switzerland, United Kingdom, United States
Outcome results
None listed