Study Stopped
The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
AWARE-2
Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
1 other identifier
observational
64
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2008
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 28, 2013
March 1, 2011
2.5 years
November 11, 2008
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
8 Weeks following last dose of each treatment course throughout study
Secondary Outcomes (1)
Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
8 Weeks following last dose of each treatment course throughout study
Study Arms (1)
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
Interventions
Commercial alefacept prescribed by Physician
Eligibility Criteria
Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
You may qualify if:
- Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma Canada, Inc.collaborator
Study Sites (21)
Unknown Facility
Edmonton, Alberta, T6J 5E5, Canada
Unknown Facility
Winnipeg, Manitoba, R3C 0N2, Canada
Unknown Facility
Winnipeg, Manitoba, R3C 1R4, Canada
Unknown Facility
Bathurst, New Brunswick, E1A 2YA, Canada
Unknown Facility
Quispamsis, New Brunswick, E2E 4Y7, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 3E1, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 1Z4, Canada
Unknown Facility
Hamilton, Ontario, L8K 6R5, Canada
Unknown Facility
London, Ontario, N6A 3H7, Canada
Unknown Facility
London, Ontario, N6H 1S9, Canada
Unknown Facility
Markham, Ontario, L3P 1A8, Canada
Unknown Facility
Oakville, Ontario, L6J 7W5, Canada
Unknown Facility
Peterborough, Ontario, K9J 1Z2, Canada
Unknown Facility
Toronto, Ontario, M4V2V6, Canada
Unknown Facility
Waterloo, Ontario, N2J 1C4, Canada
Unknown Facility
Welland, Ontario, L3C 3W4, Canada
Unknown Facility
Alma, Quebec, G8B 2V5, Canada
Unknown Facility
Montreal, Quebec, H2K 4L5, Canada
Unknown Facility
Québec, Quebec, G1J 1X7, Canada
Unknown Facility
Saint-Hyacinthe, Quebec, J2S 6L6, Canada
Biospecimen
10mL blood sample - Biomarker Substudy only
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Canada, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2008
First Posted
November 21, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 28, 2013
Record last verified: 2011-03