Clinical trial NCT00655564: Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis
Official title: Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Efficacy
timeFrame: 52 weeks
Secondary outcomes:
measure: Safety of Alefacept Using CD4 Counts
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Steven Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: