Safety and Tolerability of Repeat Courses of IM Alefacept

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00233662
First received: October 4, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: Alefacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 400
Study Start Date: December 2002
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233662

  Hide Study Locations
Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
University of California, San Francisco
San Francisco, California, United States, 94118
Clinical Research Specialists, Inc.
Santa Monica, California, United States, 90404
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06430-6231
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117
United States, New Jersey
University of Medicine and Dentistry Robert Wood Jonhson Medical School
New Brunswick, New Jersey, United States, 08903-0019
United States, New York
The Mount Sinai School of Medicine
New York, New York, United States, 10029-6547
New York University School of Medicine
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5028
United States, Tennessee
Rivergate Dermatology
Goodlettsville, Tennessee, United States, 37072-2301
United States, Texas
Baylor Dermatology Research Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Austria
University of Vienna
Vienna, Austria, A 1090
Canada, Alberta
Western Canada Dermatology Institute
Edmonton, Alberta, Canada, T5J 3S9
Canada, British Columbia
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1
Denmark
Marselisborg Hospital
Aarhus C, Denmark, DK-80000
France
CHU Henri Mondor
Creteil, France, 94010
Hopital L'Archet II
Nice, France, 6202
Hospital Saint Louis, Université Paris VII
Paris, France, 75475
Hopital Lyon Sud
Pierre-Benite, France, 69495
Germany
Humboldt Universitätsklinikum Charité
Berlin, Germany, 10117
St. Josef-Hospital
Bochum, Germany, 44791
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Heinrich-Heine-Universität
Düsseldorf, Germany, 40225
J W Goethe Universität
Frankfurt, Germany, 60590
Klinikum der Albert-Ludwig-Universität
Freiburg, Germany, 79104
Universitäts Kliniken
Göttingen, Germany, 37075
Universitätskrankenhaus Eppendorf
Hamburg, Germany, 20246
Universitätskliniken des Saarlandes
Homburg / Saar, Germany, 66421
Universität Mannhein
Mannheim, Germany, 68167
Universitätsklinikum Münster
Münster, Germany, 48149
Netherlands
AMC University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
University Hospital Nijmegen - St. Radboud
Nijmegen, Netherlands, 6500 HB
Switzerland
Hospital Cantonal
Geneva, Switzerland, 1211
United Kingdom
St. John's Institute of Dermatology
London, United Kingdom, SE1 7EH
Academic Dermatology
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Barry Ticho, MD Biogen Idec
Principal Investigator: Kenneth Gordon, MD Loyola University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233662     History of Changes
Other Study ID Numbers: C-733
Study First Received: October 4, 2005
Last Updated: October 4, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014