Alefacept Mechanism of Action in Psoriasis - Full Text View

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Biogen Idec
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00150982

Purpose

To determine the mechanism of action of alefacept in patients with psoriasis.

Condition	Intervention	Phase
Psoriasis	Drug: Mechanism of action of alefacept	Phase II

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcome Measures:

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.

Estimated Enrollment:	9
Study Start Date:	September 2003
Estimated Study Completion Date:	February 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150982

Locations

United States, New Jersey
UMDNJ Clinical Research Center
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Biogen Idec

Investigators

Principal Investigator:

Alice Gottlieb, MD, PhD

University of Medicine and Dentistry New Jersey

More Information

Study ID Numbers:	4588
Study First Received:	September 6, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00150982
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

psoriasis
alefacept

Study placed in the following topic categories:

Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009