Safety and Tolerability of Repeat Courses of IM Alefacept
NCT ID: NCT00233662
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2002-12-01
2005-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
NCT00692172
Safety and Tolerability of Repeat Courses of IM Alefacept
NCT00794807
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
NCT00673556
Alefacept Mechanism of Action in Psoriasis
NCT00150982
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
NCT00301002
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alefacept
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barry Ticho, MD
Role: STUDY_DIRECTOR
Biogen
Kenneth Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Irvine
Irvine, California, United States
University of California, San Francisco
San Francisco, California, United States
Clinical Research Specialists, Inc.
Santa Monica, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Loyola University Medical Center
Maywood, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Central Dermatology
St Louis, Missouri, United States
University of Medicine and Dentistry Robert Wood Jonhson Medical School
New Brunswick, New Jersey, United States
New York University School of Medicine
New York, New York, United States
The Mount Sinai School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Rivergate Dermatology
Goodlettsville, Tennessee, United States
Baylor Dermatology Research Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
University of Vienna
Vienna, , Austria
Western Canada Dermatology Institute
Edmonton, Alberta, Canada
Vancouver Hospital
Vancouver, British Columbia, Canada
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, Canada
Dermatrials Research
Hamilton, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Marselisborg Hospital
Aarhus C, , Denmark
CHU Henri Mondor
Créteil, , France
Hopital L'Archet II
Nice, , France
Hospital Saint Louis, Université Paris VII
Paris, , France
Hopital Lyon Sud
Pierre-Bénite, , France
Humboldt Universitätsklinikum Charité
Berlin, , Germany
St. Josef-Hospital
Bochum, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Heinrich-Heine-Universität
Düsseldorf, , Germany
J W Goethe Universität
Frankfurt, , Germany
Klinikum der Albert-Ludwig-Universität
Freiburg im Breisgau, , Germany
Universitäts Kliniken
Göttingen, , Germany
Universitätskrankenhaus Eppendorf
Hamburg, , Germany
Universitätskliniken des Saarlandes
Homburg/Saar, , Germany
Universität Mannhein
Mannheim, , Germany
Universitätsklinikum Münster
Münster, , Germany
AMC University of Amsterdam
Amsterdam, , Netherlands
University Hospital Nijmegen - St. Radboud
Nijmegen, , Netherlands
Hospital Cantonal
Geneva, , Switzerland
St. John's Institute of Dermatology
London, , United Kingdom
Academic Dermatology
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-733
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.