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

Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00795353

Acronym

AWARE-2

Enrollment

Registered

2008-11-21

Start date

2008-07-31

Completion date

2011-01-31

Last updated

2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

plaque psoriasis, psoriasis, alefacept, Amevive

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.

Interventions

DRUGAmevive exposure

Commercial alefacept prescribed by Physician

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis	8 Weeks following last dose of each treatment course throughout study

Secondary

Measure	Time frame
Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index	8 Weeks following last dose of each treatment course throughout study

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026