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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
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Edmonton, Alberta T6J 5E5, Canada; Withdrawn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

Page last updated: October 04, 2010

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