Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis (AWARE-2)

This study has been terminated.
(The study was terminated early due to insufficient subject enrolment in order to meet the primary and secondary endpoints)
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00795353
First received: November 11, 2008
Last updated: February 27, 2013
Last verified: March 2011
  Purpose

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.


Condition Intervention
Chronic Plaque Psoriasis
Drug: Amevive exposure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

10mL blood sample - Biomarker Substudy only


Enrollment: 64
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
Drug: Amevive exposure
Commercial alefacept prescribed by Physician
Other Names:
  • alefacept
  • ASP0485

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795353

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T6J 5E5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C 0N2
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E1A 2YA
Quispamsis, New Brunswick, Canada, E2E 4Y7
Canada, Newfoundland and Labrador
St. Johns, Newfoundland and Labrador, Canada, A1C 2H5
St. Johns, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, 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
Canada, Quebec
Alma, Quebec, Canada, G8B 2V5
Montreal, Quebec, Canada, H2K 4L5
Quebec City, Quebec, Canada, G1J 1X7
St. Hyacinthe, Quebec, Canada, J2S 6L6
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00795353     History of Changes
Other Study ID Numbers: A.W.A.R.E.-2
Study First Received: November 11, 2008
Last Updated: February 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
plaque psoriasis
psoriasis
alefacept
Amevive

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014