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CompletedNCT00422617Updated Jan 17, 2007

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

An interventional study of Alefacept (Amevive) in Chronic Plaque Psoriasis, sponsored by Uni-Pharma. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2007-01-17.

Sponsored by Uni-Pharma · Not applicable, Interventional, and Educational/counseling/training

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Plaque Psoriasis

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Keywords

  • psoriasis
  • alefacept
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

This is the only study on the registry with Uni-Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Educational/counseling/training
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugAlefacept (Amevive)
06

What researchers measure

Primary outcomes

  1. To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE

Secondary outcomes

  1. To determine TRR50, Quality of Life (QOL), the safety and tolerability

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00422617
Lead sponsor
Uni-Pharma
Collaborators
Biogen
First posted
Jan 17, 2007
Start date
Jan 2005
Completion
Nov 2005
Last update
Jan 17, 2007

Study contacts

Po-Han Huang
principal investigator · CGMH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2004. You cannot join it, but the record below documents what was studied.

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