Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00655564
First received: April 4, 2008
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.


Condition Intervention Phase
Psoriasis
Drug: Alefacept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Efficacy of Continuous Use of Alefacept as Defined as a 75% Reduction in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of Alefacept Using CD4 Counts and Adverse Event Reporting [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Number of participants experiencing CD4 cell counts below 250/uL or major adverse events related to treatment


Enrollment: 15
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alefacept Drug: Alefacept

Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.

Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).

Other Name: Amevive®

Detailed Description:

To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).

  Eligibility

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

Inclusion Criteria:

  • Must give written informed consent.
  • Subjects must be 18 years of age or older.
  • Subject must be adult males or non-pregnant, non-lactating females.
  • Female subjects of childbearing potential must state that they are using measures to avoid conception through active means including hormone replacement, intrauterine device, or abstinence.
  • Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
  • Subjects must be willing to receive an IM injection per protocol for 1 year.
  • Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1. Objectively this equates to

Inclusion criteria of either:

  • IGA≥3 on a 0-5 scale and BSA≥10%
  • PASI ≥12

    • Subjects may not be taking any other systemic therapies or receiving phototherapy during the duration of the study. Subjects are required a 4 week washout period from any systemic medication or phototherapy prior to enrolling in the study and starting treatment with alefacept.
    • There is no washout for topical corticosteroid medications. Stable dosing of topical corticosteroids may be used up until the first dosing visit.

Exclusion Criteria:

  • Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  • Subjects have guttate, pustular, erythrodermic or rapidly flaring psoriasis.
  • Current enrollment in any research study.
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
  • Any subject who has a CD4<250 cells/µL at study entry.
  • Treatment with another investigational drug or approved therapy within 28 days prior to study drug administration.
  • Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
  • Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
  • Known HIV+, known viral Hepatitis infection, known tuberculosis infection.
  • History of systemic malignancy.
  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: NCT00655564

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Steven Feldman, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier: NCT00655564     History of Changes
Other Study ID Numbers: 00004816, 32547 Contract number
Study First Received: April 4, 2008
Results First Received: June 27, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014