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

NCT ID: NCT00422617

Last Updated: 2007-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-11-30

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.

Conditions

Chronic Plaque Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Alefacept (Amevive)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Uni-Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Po-Han Huang

Role: PRINCIPAL_INVESTIGATOR

CGMH

Other Identifiers

ASIA-7002

Identifier Type: -

Identifier Source: org_study_id