Safety and Tolerability of Repeat Courses of IM Alefacept
- Conditions
- Chronic Plaque Psoriasis
- Registration Number
- NCT00233662
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (46)
Dermatrials Research
🇨🇦Hamilton, Ontario, Canada
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Hopital L'Archet II
🇫🇷Nice, France
New York University School of Medicine
🇺🇸New York, New York, United States
The Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Central Dermatology
🇺🇸Saint Louis, Missouri, United States
Klinikum der Albert-Ludwig-Universität
🇩🇪Freiburg, Germany
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Clinical Research Specialists, Inc.
🇺🇸Santa Monica, California, United States
Academic Dermatology
🇬🇧Salford, United Kingdom
Universitäts Kliniken
🇩🇪Göttingen, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
CHU Henri Mondor
🇫🇷Creteil, France
Hopital Lyon Sud
🇫🇷Pierre Benite, France
Humboldt Universitätsklinikum Charité
🇩🇪Berlin, Germany
J W Goethe Universität
🇩🇪Frankfurt, Germany
St. Josef-Hospital
🇩🇪Bochum, Germany
Universitätskliniken des Saarlandes
🇩🇪Homburg/Saar, Germany
Heinrich-Heine-Universität
🇩🇪Düsseldorf, Germany
University of Medicine and Dentistry Robert Wood Jonhson Medical School
🇺🇸New Brunswick, New Jersey, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
University of Vienna
🇦🇹Vienna, Austria
AMC University of Amsterdam
🇳🇱Amsterdam, Netherlands
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Eastern Canada Cutaneous Research Associates
🇨🇦Halifax, Nova Scotia, Canada
University Hospital Nijmegen - St. Radboud
🇳🇱Nijmegen, Netherlands
Hospital Cantonal
🇨🇭Geneva, Switzerland
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Dermatology Associates
🇺🇸Seattle, Washington, United States
St. John's Institute of Dermatology
🇬🇧London, United Kingdom
Marselisborg Hospital
🇩🇰Aarhus C, Denmark
Universitätskrankenhaus Eppendorf
🇩🇪Hamburg, Germany
Universität Mannhein
🇩🇪Mannheim, Germany
Baylor Dermatology Research Center
🇺🇸Dallas, Texas, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Western Canada Dermatology Institute
🇨🇦Edmonton, Alberta, Canada
Rivergate Dermatology
🇺🇸Goodlettsville, Tennessee, United States
Vancouver Hospital
🇨🇦Vancouver, British Columbia, Canada
Hospital Saint Louis, Université Paris VII
🇫🇷Paris, France