ActivePhase 3Phase 4ACTRN12605000295640
An Open-Label, Multicentre Study to Evaluate the Duration of Clinical Remission of Two Courses of Weekly Intramuscular administration of AMEVIVE (alefacept) by evaluating the time to retreatment with AMEVIVE or an alternative systemic therapy in patients with chronic plaque psoriasis in the context of standard dermatological practice
Sponsor
Biogen Idec
Enrollment
100 participants
Start Date
Jul 4, 2003
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 16 Yearss
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
One or two courses of Amevive (alefacept) 15mg im weekly for 12 weeks.
One or two courses of Amevive (alefacept) 15mg im weekly for 12 weeks.
Locations(1)
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ACTRN12605000295640