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Alefacept Mechanism of Action in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00150982
First received: September 6, 2005
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: Mechanism of action of alefacept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of 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
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, see Learn About Clinical Studies.

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 of New Jersey
Biogen Idec
Investigators
Principal Investigator: Alice Gottlieb, MD, PhD Rutgers, The State University of New Jersey
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Alefacept
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014