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

NCT ID: NCT00795353

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.

Conditions

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Chronic Plaque Psoriasis

Keywords

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plaque psoriasis psoriasis alefacept Amevive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1. Amevive Exposure

Canadian subjects with moderate to severe chronic plaque psoriasis

Amevive exposure

Intervention Type DRUG

Commercial alefacept prescribed by Physician

Interventions

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Amevive exposure

Commercial alefacept prescribed by Physician

Intervention Type DRUG

Other Intervention Names

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alefacept ASP0485

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Canada, Inc.

Locations

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Edmonton, Alberta, Canada

Site Status

Winnipeg, Manitoba, Canada

Site Status

Winnipeg, Manitoba, Canada

Site Status

Bathurst, New Brunswick, Canada

Site Status

Quispamsis, New Brunswick, Canada

Site Status

St. John's, Newfoundland and Labrador, Canada

Site Status

St. John's, Newfoundland and Labrador, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Hamilton, Ontario, Canada

Site Status

London, Ontario, Canada

Site Status

London, Ontario, Canada

Site Status

Markham, Ontario, Canada

Site Status

Oakville, Ontario, Canada

Site Status

Peterborough, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Waterloo, Ontario, Canada

Site Status

Welland, Ontario, Canada

Site Status

Alma, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Québec, Quebec, Canada

Site Status

Saint-Hyacinthe, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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A.W.A.R.E.-2

Identifier Type: -

Identifier Source: org_study_id