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

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alefacept (Amevive)
Sponsored by
Uni-Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Chronic Plaque Psoriasis focused on measuring psoriasis, alefacept

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 16, 2007
    Last Updated
    January 16, 2007
    Sponsor
    Uni-Pharma
    Collaborators
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00422617
    Brief Title
    Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Uni-Pharma
    Collaborators
    Biogen

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Plaque Psoriasis
    Keywords
    psoriasis, alefacept

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Alefacept (Amevive)
    Primary Outcome Measure Information:
    Title
    To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
    Secondary Outcome Measure Information:
    Title
    To determine TRR50, Quality of Life (QOL), the safety and tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Po-Han Huang
    Organizational Affiliation
    CGMH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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