- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795353
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis (AWARE-2)
February 27, 2013 updated by: Astellas Pharma Inc
Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6J 5E5
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
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Winnipeg, Manitoba, Canada, R3C 1R4
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New Brunswick
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Bathurst, New Brunswick, Canada, E1A 2YA
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Quispamsis, New Brunswick, Canada, E2E 4Y7
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
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St. Johns, Newfoundland and Labrador, Canada, A1C 2H5
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1Z4
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Ontario
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Hamilton, Ontario, Canada, L8K 6R5
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London, Ontario, Canada, N6A 3H7
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London, Ontario, Canada, N6H 1S9
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Markham, Ontario, Canada, L3P 1A8
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Oakville, Ontario, Canada, L6J 7W5
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Peterborough, Ontario, Canada, K9J 1Z2
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Toronto, Ontario, Canada, M4V2V6
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Waterloo, Ontario, Canada, N2J 1C4
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Welland, Ontario, Canada, L3C 3W4
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Quebec
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Alma, Quebec, Canada, G8B 2V5
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Montreal, Quebec, Canada, H2K 4L5
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Quebec City, Quebec, Canada, G1J 1X7
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St. Hyacinthe, Quebec, Canada, J2S 6L6
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
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Commercial alefacept prescribed by Physician
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
Time Frame: 8 Weeks following last dose of each treatment course throughout study
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8 Weeks following last dose of each treatment course throughout study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
Time Frame: 8 Weeks following last dose of each treatment course throughout study
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8 Weeks following last dose of each treatment course throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
November 11, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Estimate)
February 28, 2013
Last Update Submitted That Met QC Criteria
February 27, 2013
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A.W.A.R.E.-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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