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OpenTrials
Completed

NCT Number: NCT00422617

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

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alefacept (Amevive)

Drug

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

Sponsors and collaborators

Lead sponsor

Uni-Pharma

Industry

Collaborators

  • Biogen

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Jan 17, 2007
Registry last updated
Jan 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.