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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT00233662

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 46 Locations for this study

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University of California, Irvine
Irvine California, 92697, United States
University of California, San Francisco
San Francisco California, 94118, United States
Clinical Research Specialists, Inc.
Santa Monica California, 90404, United States
University of Connecticut Health Center
Farmington Connecticut, 06430, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Central Dermatology
Saint Louis Missouri, 63117, United States
University of Medicine and Dentistry Robert Wood Jonhson Medical School
New Brunswick New Jersey, 08903, United States
New York University School of Medicine
New York New York, 10016, United States
The Mount Sinai School of Medicine
New York New York, 10029, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem North Carolina, 27157, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Rivergate Dermatology
Goodlettsville Tennessee, 37072, United States
Baylor Dermatology Research Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah School of Medicine
Salt Lake City Utah, 84132, United States
Virginia Clinical Research, Inc.
Norfolk Virginia, 23507, United States
Dermatology Associates
Seattle Washington, 98101, United States
University of Vienna
Vienna , A 109, Austria
Western Canada Dermatology Institute
Edmonton Alberta, T5J 3, Canada
Vancouver Hospital
Vancouver British Columbia, V5Z 4, Canada
Eastern Canada Cutaneous Research Associates
Halifax Nova Scotia, B3H 1, Canada
Dermatrials Research
Hamilton Ontario, L8N 1, Canada
Royal Victoria Hospital
Montreal Quebec, H3A1A, Canada
Marselisborg Hospital
Aarhus C , DK-80, Denmark
CHU Henri Mondor
Creteil , 94010, France
Hopital L'Archet II
Nice , 6202, France
Hospital Saint Louis, Université Paris VII
Paris , 75475, France
Hopital Lyon Sud
Pierre Benite , 69495, France
Humboldt Universitätsklinikum Charité
Berlin , 10117, Germany
St. Josef-Hospital
Bochum , 44791, Germany
Universitätsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Heinrich-Heine-Universität
Düsseldorf , 40225, Germany
J W Goethe Universität
Frankfurt , 60590, Germany
Klinikum der Albert-Ludwig-Universität
Freiburg , 79104, Germany
Universitäts Kliniken
Göttingen , 37075, Germany
Universitätskrankenhaus Eppendorf
Hamburg , 20246, Germany
Universitätskliniken des Saarlandes
Homburg/Saar , 66421, Germany
Universität Mannhein
Mannheim , 68167, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
AMC University of Amsterdam
Amsterdam , 1105 , Netherlands
University Hospital Nijmegen - St. Radboud
Nijmegen , 6500 , Netherlands
Hospital Cantonal
Geneva , 1211, Switzerland
St. John's Institute of Dermatology
London , SE1 7, United Kingdom
Academic Dermatology
Salford , M6 8H, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

400

Study ID:

NCT00233662

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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