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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