Psoriasis Clinical Trial
Safety and Tolerability of Repeat Courses of IM Alefacept
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.
Eligibility Criteria
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.
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There are 46 Locations for this study
Irvine California, 92697, United States
San Francisco California, 94118, United States
Santa Monica California, 90404, United States
Farmington Connecticut, 06430, United States
Maywood Illinois, 60153, United States
Boston Massachusetts, 02114, United States
Saint Louis Missouri, 63117, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10016, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Goodlettsville Tennessee, 37072, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98101, United States
Vienna , A 109, Austria
Edmonton Alberta, T5J 3, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8N 1, Canada
Montreal Quebec, H3A1A, Canada
Aarhus C , DK-80, Denmark
Creteil , 94010, France
Nice , 6202, France
Paris , 75475, France
Pierre Benite , 69495, France
Berlin , 10117, Germany
Bochum , 44791, Germany
Dresden , 01307, Germany
Düsseldorf , 40225, Germany
Frankfurt , 60590, Germany
Freiburg , 79104, Germany
Göttingen , 37075, Germany
Hamburg , 20246, Germany
Homburg/Saar , 66421, Germany
Mannheim , 68167, Germany
Münster , 48149, Germany
Amsterdam , 1105 , Netherlands
Nijmegen , 6500 , Netherlands
Geneva , 1211, Switzerland
London , SE1 7, United Kingdom
Salford , M6 8H, United Kingdom
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