Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Terminated
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Drug: Amevive exposure
- Registration Number
- NCT00795353
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.
- Detailed Description
Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
Exclusion Criteria
- Subjects with a contraindication to alefacept
- Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
- Subjects with any active cancer, including skin cancer
- Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
- Subjects known to be infected with the AIDS virus
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1. Amevive Exposure Amevive exposure Canadian subjects with moderate to severe chronic plaque psoriasis
- Primary Outcome Measures
Name Time Method Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis 8 Weeks following last dose of each treatment course throughout study
- Secondary Outcome Measures
Name Time Method Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index 8 Weeks following last dose of each treatment course throughout study