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

Astellas

Status: Terminated

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Amevive exposure

Study type: Observational

Funder types: Industry

Identifiers

NCT00795353

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

Details and patient eligibility

About

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.

Full description

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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 1 patient group

1. Amevive Exposure

Description:

Canadian subjects with moderate to severe chronic plaque psoriasis

Treatment:

Drug: Amevive exposure