Alefacept Mechanism of Action in Psoriasis
Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Mechanism of action of alefacept (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Medicine and Dentistry of New Jersey Official(s) and/or principal investigator(s): Alice Gottlieb, MD, PhD, Principal Investigator, Affiliation: Rutgers, The State University of New Jersey
Summary
To determine the mechanism of action of alefacept in patients with psoriasis.
Clinical Details
Official title: In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
Secondary outcome: To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
UMDNJ Clinical Research Center, New Brunswick, New Jersey 08903, United States
Additional Information
Starting date: September 2003
Last updated: August 6, 2008
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