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
- Conditions
- Chronic plaque psoriasisSkin - Dermatological conditions
- Registration Number
- ACTRN12605000295640
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to retreatment with AMEVIVE or an alternative systemic therapy[Patients are followed up at monthly intervals after completion of the 12-week dosing phase until they are deemed to require retreatment by the investigator]
- Secondary Outcome Measures
Name Time Method To determine the safety and tolerability of two courses of alefacept given alone patients with chronic plaque psoriasis. [atients are followed-up at monthly intervals after completion of the 12-week dosing phase until they are deemed to require retreatment by the investigator.];To determine the effect of AMEVIVE on patients' Quality of Life (QOL).[At baseline, day 92, day 162 and then monthly after completion of a second course until the patient is deemed to require retreatment by the investigator.]