Alefacept Mechanism of Action in Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150982
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 7, 2008
Information provided by:
Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Mechanism of action of alefacept Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Primary Outcome Measures :
  1. To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150982

United States, New Jersey
UMDNJ Clinical Research Center
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Alice Gottlieb, MD, PhD Rutgers, The State University of New Jersey Identifier: NCT00150982     History of Changes
Other Study ID Numbers: 4588
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: August 2008

Keywords provided by Rutgers, The State University of New Jersey:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents