Clinical trial NCT00233662: Safety and Tolerability of Repeat Courses of IM Alefacept
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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 outcomes:
measure: 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).
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: Clinical Research Specialists, Inc.
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry Robert Wood Jonhson Medical School
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: The Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Dallas
country: United States
facility: Baylor Dermatology Research Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Vienna
country: Austria
facility: University of Vienna
city: Edmonton
country: Canada
facility: Western Canada Dermatology Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Aarhus C
country: Denmark
facility: Marselisborg Hospital
city: Creteil
country: France
facility: CHU Henri Mondor
city: Nice
country: France
facility: Hopital L'Archet II
city: Paris
country: France
facility: Hospital Saint Louis, Université Paris VII
city: Pierre Benite
country: France
facility: Hopital Lyon Sud
city: Berlin
country: Germany
facility: Humboldt Universitätsklinikum Charité
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität
city: Frankfurt
country: Germany
facility: J W Goethe Universität
city: Freiburg
country: Germany
facility: Klinikum der Albert-Ludwig-Universität
city: Göttingen
country: Germany
facility: Universitäts Kliniken
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Eppendorf
city: Homburg/Saar
country: Germany
facility: Universitätskliniken des Saarlandes
city: Mannheim
country: Germany
facility: Universität Mannhein
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Amsterdam
country: Netherlands
facility: AMC University of Amsterdam
city: Nijmegen
country: Netherlands
facility: University Hospital Nijmegen - St. Radboud
city: Geneva
country: Switzerland
facility: Hospital Cantonal
city: London
country: United Kingdom
facility: St. John's Institute of Dermatology
city: Salford
country: United Kingdom
facility: Academic Dermatology
Study officials:
affiliation: Biogen
name: Barry Ticho, MD
role: STUDY_DIRECTOR
affiliation: Loyola University
name: Kenneth Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References: