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

UNI Pharma

Status

Completed

Conditions

Chronic Plaque Psoriasis

Treatments

Drug: Alefacept (Amevive)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422617

ASIA-7002

Details and patient eligibility

About

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

Full description

The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.