None listed
Conditions
Interventions
One or two courses of Amevive (alefacept) 15mg im weekly for 12 weeks.
Sponsors
Biogen Idec
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must give written informed consent. 2. Must have been diagnosed with chronic plaque psoriasis and require systemic therapy. 3. Must have CD4+ lymphocyte counts at or above the lower limit of normal.
Exclusion criteria
1. Current erythrodermic, generalized pustular, or guttate psoriasis. 2. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to the first dose of alefacept. 3. History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would be contraindicated for this study as determined by the investigator. 4. Prior history of systemic malignancy, untreated localised skin cancer or a >10 squamous cell carcinoma that have been previously treated. 5. Current enrollment in any other investigational drug study within 30 days prior to study drug administration. 6. Current treatment with any therapy for active tuberculosis or tuberculosis prophylaxis. 9. Female patients who are currently pregnant or breast-feeding.
Outcome results
None listed