Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
NCT ID: NCT00371774
Last Updated: 2011-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
426 participants
OBSERVATIONAL
2005-06-30
2008-05-31
Brief Summary
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To develop a real time national clinical database to support and share best practices,
1. To generate hypotheses for future clinical research
2. To understand how AMEVIVE is used in routine clinical practice/real world setting.
Each patient visit will include the following observational endpoints:
1. AMEVIVE dosing
2. Number of courses
3. Concomitant treatment
4. Response to treatment (patient and physician global assessments)
5. Status of other psoriasis-related medical conditions
6. Time to re-treatment.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Dermatologic patients in Canada for which Amevive is clinically indicated
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Canada, Inc.
Locations
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Calgary, Alberta, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Moncton, New Brunswick, Canada
Saint John, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
Concord, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sainte-Foy, Quebec, Canada
Countries
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References
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Searles G, Bissonnette R, Landells I, Shear NH. Preface: real-world clinical experience with alefacept-the Amevive Wisdom Acquired from Real-World Evidence (AWARE) study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S107-12. doi: 10.2310/7750.2009.00028. No abstract available.
Bissonnette R, Searles G, Landells I, Shear NH, Papp K, Lui H, Gulliver WP, Lynde C. The AWARE study: methodology and baseline characteristics. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S113-21. doi: 10.2310/7750.2009.00029.
Landells I, Searles G, Bissonnette R, Shear NH, Vender R, Lui H. Efficacy outcomes in patients using alefacept in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S122-30. doi: 10.2310/7750.2009.00030.
Searles G, Bissonnette R, Landells I, Shear NH, Papp K, Lui H. Patterns of combination therapy with alefacept for the treatment of psoriasis in Canada in the AWARE study. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S131-8. doi: 10.2310/7750.2009.00031.
Wexler D, Searles G, Landells I, Shear NH, Bissonnette R, Papp K, Poulin Y, Langley R, Gulliver WP. Update on alefacept safety. J Cutan Med Surg. 2009 Dec;13 Suppl 3:S139-47. doi: 10.2310/7750.2009.00032.
Related Links
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Link to FDA Website
Other Identifiers
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CA-08
Identifier Type: -
Identifier Source: org_study_id
NCT00214799
Identifier Type: -
Identifier Source: nct_alias