ACTRN12605000295640
Active, not recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic plaque psoriasis
- Sponsor
- Biogen Idec
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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