Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Plaque Psoriasis
Intervention: Amevive exposure (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.
Overall contact:
Astellas Pharma Canada R&D Medical Information, Phone: 888-338-1824
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.
Clinical Details
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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Astellas Pharma Canada R&D Medical Information, Phone: 888-338-1824
Calgary, Alberta T2S 3B3, Canada; Recruiting
Edmonton, Alberta T6J 5E5, Canada; Withdrawn
Edmonton, Alberta T5K 1X3, Canada; Recruiting
Vancouver, British Columbia V5Z4E8, Canada; Recruiting
Winnipeg, Manitoba R3C 0N2, Canada; Recruiting
Winnipeg, Manitoba R3C 1R4, Canada; Recruiting
Bathurst, New Brunswick E1A 2YA, Canada; Terminated
Quispamsis, New Brunswick E2E 4Y7, Canada; Recruiting
St. Johns, Newfoundland and Labrador A1C 2H5, Canada; Recruiting
St. Johns, Newfoundland and Labrador A1B 3E1, Canada; Recruiting
Halifax, Nova Scotia B3H 1Z4, Canada; Recruiting
Hamilton, Ontario L8K 6R5, Canada; Terminated
Hawkesbury, Ontario K6A 3B2, Canada; Withdrawn
London, Ontario N6A 3H7, Canada; Terminated
London, Ontario N6H 1S9, Canada; Recruiting
Markham, Ontario L3P 1A8, Canada; Recruiting
Oakville, Ontario L6J 7W5, Canada; Terminated
Peterborough, Ontario K9J 1Z2, Canada; Recruiting
Sudbury, Ontario P3E 5M4, Canada; Withdrawn
Tecumseh, Ontario N8N 1M2, Canada; Withdrawn
Toronto, Ontario M4V2V6, Canada; Recruiting
Waterloo, Ontario N2J 1C4, Canada; Recruiting
Welland, Ontario L3C 3W4, Canada; Terminated
Alma, Quebec G8B 2V5, Canada; Recruiting
Montreal, Quebec H2K 4L5, Canada; Recruiting
Quebec City, Quebec G1J 1X7, Canada; Recruiting
St. Hyacinthe, Quebec J2S 6L6, Canada; Recruiting
Additional Information
Starting date: July 2008
Last updated: September 22, 2010
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