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

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

    • Alberta
      • Edmonton, Alberta, Canada, T6J 5E5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg, Manitoba, Canada, R3C 1R4
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E1A 2YA
      • Quispamsis, New Brunswick, Canada, E2E 4Y7
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
      • St. Johns, Newfoundland and Labrador, Canada, A1C 2H5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
    • Ontario
      • Hamilton, Ontario, Canada, L8K 6R5
      • London, Ontario, Canada, N6A 3H7
      • London, Ontario, Canada, N6H 1S9
      • Markham, Ontario, Canada, L3P 1A8
      • Oakville, Ontario, Canada, L6J 7W5
      • Peterborough, Ontario, Canada, K9J 1Z2
      • Toronto, Ontario, Canada, M4V2V6
      • Waterloo, Ontario, Canada, N2J 1C4
      • Welland, Ontario, Canada, L3C 3W4
    • Quebec
      • Alma, Quebec, Canada, G8B 2V5
      • Montreal, Quebec, Canada, H2K 4L5
      • Quebec City, Quebec, Canada, G1J 1X7
      • St. Hyacinthe, Quebec, Canada, J2S 6L6

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
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
Commercial alefacept prescribed by Physician
Other Names:
  • ASP0485
  • alefacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 Weeks following last dose of each treatment course throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 Weeks following last dose of each treatment course throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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