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

Not Applicable

Completed

• Conditions: Chronic Plaque Psoriasis

• Registration Number: NCT00422617
• Lead Sponsor: Uni-Pharma

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2004-09
• Study Start: 2005-01
• Study Completion: 2005-11
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Last Update Submitted: 2007-01-16
• Study First Posted: 2007-01-17
• Last Update Posted: 2007-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE

Secondary Outcome Measures

Name	Time	Method
To determine TRR50, Quality of Life (QOL), the safety and tolerability