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ClinicalTrials.gov Identifier: NCT00150982
Recruitment Status :
First Posted : September 8, 2005
Last Update Posted : August 7, 2008
University of Medicine and Dentistry of New Jersey
To determine the mechanism of action of alefacept in patients with psoriasis.
Condition or disease
Drug: Mechanism of action of alefacept
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 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).
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