Status:
COMPLETED
Alefacept Mechanism of Action in Psoriasis
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Biogen
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the mechanism of action of alefacept in patients with psoriasis.
Detailed Description
The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 we...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).
- Exclusion Criteria
- CD4 \< 400/ml
- WBC less than lower level of normal for the reporting laboratory
- \< 5% Body Surface Area involved with psoriasis
- Serious infection e.g., latent or active tuberculosis
- History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
- Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
- Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
- Inability to understand consent form or comply with study requirements
- Pregnancy or lactation
- Concurrent medical illness that would make participation in this clinical trial ill-advised
- Any contraindications to using alefacept
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00150982
Start Date
September 1 2003
End Date
February 1 2005
Last Update
August 7 2008
Active Locations (1)
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1
UMDNJ Clinical Research Center
New Brunswick, New Jersey, United States, 08903