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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

Page last updated: August 20, 2015

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