Status:
COMPLETED
Safety and Tolerability of Repeat Courses of IM Alefacept
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Biogen
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larg...
Detailed Description
Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated...
Eligibility Criteria
Inclusion
- Must give written informed consent.
- Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.
Exclusion
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
- Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
- Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
- Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
- Known HIV+, known viral Hepatitis infection, known tuberculosis infection.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00794807
Start Date
February 1 2004
End Date
December 1 2005
Last Update
November 20 2008
Active Locations (1)
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1
Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology
Berlin, State of Berlin, Germany, 10117