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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


Phase 3
16 Years
N/A
Not Enrolling
Both
Chronic Plaque Psoriasis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Barry Ticho, MD

Investigator Role:

Study Director

Investigator Affiliation:

Biogen Idec

Authority:

United States: Food and Drug Administration

Study ID:

C-733

NCT ID:

NCT00233662

Start Date:

December 2002

Completion Date:

June 2005

Related Keywords:

  • Chronic Plaque Psoriasis
  • Psoriasis

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096
Loyola University Medical Center Maywood, Illinois  60153
University Hospitals of Cleveland Cleveland, Ohio  44106
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of California, San Francisco San Francisco, California  94143
Duke University Medical Center Durham, North Carolina  27710
New York University School of Medicine New York, New York  10016
University of California, Irvine Orange, California  92868
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Rivergate Dermatology Goodlettsville, Tennessee  37072
Clinical Research Specialists, Inc. Santa Monica, California  90404
Central Dermatology St. Louis, Missouri  63117
University of Medicine and Dentistry Robert Wood Jonhson Medical School New Brunswick, New Jersey  08903-0019
The Mount Sinai School of Medicine New York, New York  10029-6547
Baylor Dermatology Research Center Dallas, Texas  75246
University of Utah School of Medicine Salt Lake City, Utah  84132
Virginia Clinical Research, Inc. Norfolk, Virginia  23507
Dermatology Associates Seattle, Washington  98101