Clinical trial NCT00795353: Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Plaque Psoriasis
Keywords: plaque psoriasis
psoriasis
alefacept
Amevive
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2008-11-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian subjects with moderate to severe chronic plaque psoriasis for which Amevive is clinically indicated

Brief summary: 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.

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 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

Primary outcomes:
measure: Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
timeFrame: 8 Weeks following last dose of each treatment course throughout study
Secondary outcomes:
measure: Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index
timeFrame: 8 Weeks following last dose of each treatment course throughout study
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Winnipeg
country: Canada
state: Manitoba
city: Bathurst
country: Canada
state: New Brunswick
city: Quispamsis
country: Canada
state: New Brunswick
city: St. Johns
country: Canada
state: Newfoundland and Labrador
city: St. Johns
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Welland
country: Canada
state: Ontario
city: Alma
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: St. Hyacinthe
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References: