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

Chronic Plaque Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422617
• Other study ID #: ASIA-7002
• Status: Completed
• Phase: N/A
• First received: January 16, 2007
• Last updated: January 16, 2007
• Start date: January 2005
• Est. completion date: November 2005

Study information

• Verified date: September 2004
• Source: Uni-Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Alefacept (Amevive)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uni-Pharma	Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
Secondary	To determine TRR50, Quality of Life (QOL), the safety and tolerability