Status:
TERMINATED
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00795353
Start Date
July 1 2008
End Date
January 1 2011
Last Update
February 28 2013
Active Locations (21)
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1
Edmonton, Alberta, Canada, T6J 5E5
2
Winnipeg, Manitoba, Canada, R3C 0N2
3
Winnipeg, Manitoba, Canada, R3C 1R4
4
Bathurst, New Brunswick, Canada, E1A 2YA