Overview

Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients

Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
0
Participant gender:
All
Summary
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Uni-Pharma
Collaborator:
Biogen
Treatments:
Alefacept
Criteria
Inclusion Criteria:

- Must give written informed consent

- Must be >= 16 years of age

- Must have been diagnosed with chronic plaque psoriasis at least one year and require
systemic or phototherapy

- Must have CD4+ lymphocyte count at or above the lower limit of normal

- Must have a BSA >= 10%

Exclusion Criteria:

- Current erythrodermic, generalized pustular, or guttate psoriasis

- Serious local infection or systemic infection within 3 months prior to the first dose
of alefacept

- History of any clinical significant disease that would be contraindicated for this
study as determined by the investigator

- Prior history of systemic malignancy, untreated localised skin canceer or a >10
squamous cell carcinoma

- Current enrollment in any other investigational drug study within 30 days prior to
study drug administration

- Treatment with systemic immunosuppressant agents within the 4 weeks prior to study
drug administration.