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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Uni-Pharma
ClinicalTrials.gov Identifier:
NCT00422617
First received: January 16, 2007
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

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


Condition Intervention
Chronic Plaque Psoriasis
Drug: Alefacept (Amevive)

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

Resource links provided by NLM:


Further study details as provided by Uni-Pharma:

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

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422617

Sponsors and Collaborators
Uni-Pharma
Biogen Idec
Investigators
Principal Investigator: Po-Han Huang CGMH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422617     History of Changes
Other Study ID Numbers: ASIA-7002
Study First Received: January 16, 2007
Last Updated: January 16, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Uni-Pharma:
psoriasis
alefacept

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014