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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422617

Enrollment

Registered

2007-01-17

Start date

2005-01-31

Completion date

2005-11-30

Last updated

2007-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

psoriasis, alefacept

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.

Interventions

DRUGAlefacept (Amevive)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

ECT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE	—

Secondary

Measure	Time frame
To determine TRR50, Quality of Life (QOL), the safety and tolerability	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026