Status:
COMPLETED
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
Lead Sponsor:
Uni-Pharma
Collaborating Sponsors:
Biogen
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
16+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00422617
Start Date
January 1 2005
End Date
November 1 2005
Last Update
January 17 2007
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