Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program
Overview
Purpose: 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.
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2008
Arms, Groups and Cohorts
- 1
- Dermatologic patients in Canada for which Amevive is clinically indicated
Clinical Trial Outcome Measures
Primary Measures
- Understand how AMEVIVE is used in routine clinical practice/real world setting
- Time Frame: End of study
Participating in This Clinical Trial
Inclusion Criteria
- Amevive is clinically indicated for the patient Exclusion Criteria:
- Amevive is contraindicated for the patient
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Astellas Pharma Inc
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Use Central Contact, Study Director, Astellas Pharma Canada, Inc.
References
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.
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