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Safety and Tolerability of Repeat Courses of IM Alefacept

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00233662
First received: October 4, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted

October 4, 2005
October 4, 2005
December 2002
Not Provided
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
Same as current
No Changes Posted
Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Repeat Courses of IM Alefacept
An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Plaque Psoriasis
Drug: Alefacept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2005
Not Provided

Inclusion Criteria:

  • Written informed consent.
  • At least 16 years of age.
  • Diagnosed with chronic plaque psoriasis and require systemic therapy.
  • CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).

Exclusion Criteria:

  • Unstable erthrodermic or pustular psoriasis.
  • Diagnosis of guttate psoriasis.
  • Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
  • Positive for HIV antibody.
  • Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
  • Evidence of active tuberculosis.
  • Current treatment for active tuberculosis or tuberculosis prophylaxis.
  • Female patients unwilling to practice effective contraception as defined by the investigator.
  • Female patients who are pregnant or breast-feeding.
  • Current enrollment in any other investigational drug study.
  • Previous participation in this study or previous alefacept studies.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Denmark,   France,   Germany,   Netherlands,   Switzerland,   United Kingdom
 
NCT00233662
C-733
Not Provided
Not Provided
Biogen Idec
Not Provided
Study Director: Barry Ticho, MD Biogen Idec
Principal Investigator: Kenneth Gordon, MD Loyola University
Biogen Idec
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP