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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)

Phase: N/A

Status: Terminated

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 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

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

Additional Information

Link to results on JAPIC

Starting date: July 2008
Last updated: February 27, 2013

Page last updated: August 20, 2015

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