Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Plaque Psoriasis
Intervention: Amevive exposure (Drug)
Sponsored by: Astellas Pharma Inc
Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.
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
Official title: Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
Secondary outcome: Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
Study includes a bio-marker sub-study to determine differences in responders vs.
non-responders. Additional consent is required for the sub-study.
Minimum age: 18 Years.
Maximum age: N/A.
- Subjects with moderate to severe chronic plaque psoriasis who receive a new
prescription for alefacept
- 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
Locations and Contacts
Edmonton, Alberta T6J 5E5, Canada
Winnipeg, Manitoba R3C 0N2, Canada
Winnipeg, Manitoba R3C 1R4, Canada
Bathurst, New Brunswick E1A 2YA, Canada
Quispamsis, New Brunswick E2E 4Y7, Canada
St. Johns, Newfoundland and Labrador A1C 2H5, Canada
St. Johns, Newfoundland and Labrador A1B 3E1, Canada
Halifax, Nova Scotia B3H 1Z4, Canada
Hamilton, Ontario L8K 6R5, Canada
London, Ontario N6A 3H7, Canada
London, Ontario N6H 1S9, Canada
Markham, Ontario L3P 1A8, Canada
Oakville, Ontario L6J 7W5, Canada
Peterborough, Ontario K9J 1Z2, Canada
Toronto, Ontario M4V2V6, Canada
Waterloo, Ontario N2J 1C4, Canada
Welland, Ontario L3C 3W4, Canada
Alma, Quebec G8B 2V5, Canada
Montreal, Quebec H2K 4L5, Canada
Quebec City, Quebec G1J 1X7, Canada
St. Hyacinthe, Quebec J2S 6L6, Canada
Link to results on JAPIC
Starting date: July 2008
Last updated: February 27, 2013