Community Based Trial for AMEVIVE®

Completed · Phase 4

Conditions studied: Moderate to Severe Chronic Plaque Psoriasis

In brief

To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.

Key facts

Study ID

NCT00168753

Run by

Astellas Pharma Inc

People needed

114

Starts

2004-07-01

Expected to finish

2005-03-01

Last updated by the study team

2014-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must give written informed consent.
• Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
• Must be 18 years of age or older.
• Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
• Response to current AMEVIVE therapy must be less than a desired response as determined by the physician, and subject and some residual psoriasis must be present.

You may not qualify if…

• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
• Nursing mothers, pregnant women, and women planning to become pregnant
• Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
• Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
• Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mycophenolate mofetil or other systemic immunosuppressant agents within 4 weeks of investigational drug administration.
• Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
• 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.
• History of >3 cutaneous squamous cell carcinomas or any systemic malignancy.
• Skin lesions suspicious for malignancy.
• Known HIV, viral hepatitis, or tuberculosis infection.
• History of severe allergic or anaphylactic reactions.
• ALT or AST greater than three times the upper limit of normal.
• Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
• CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
• Known hypersensitivity to AMEVIVE or any of its components.
• Subject's inability to comply with study requirements.

Where it is running

• Monheit Dermatology Associates — Birmingham, Alabama, United States
• Bayshore Dermatology — Fairhope, Alabama, United States
• Jayne Fortson — Anchorage, Alaska, United States
• Bakersfield Dermatology & Skin Cancer Medical Group — Bakersfield, California, United States
• Integrated Research Group — Riverside, California, United States
• Robert Greenberg — San Ramon, California, United States
• Front Dermatology — Denver, Colorado, United States
• Skin and Cancer Associates — Tamarac, Florida, United States
• Michael Scannon — Tampa, Florida, United States
• Atlanta Derm, Vein & Research Center — Alpharetta, Georgia, United States
• Pearlridge Dermatology — ‘Aiea, Hawaii, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Calumet Dermatology Associates — Calumet City, Illinois, United States
• Michael Greenberg — Elk Grove Village, Illinois, United States
• David J. Coynik — Peru, Illinois, United States
• Melissa Knuckles — Corbin, Kentucky, United States
• Richard Eisen — Plymouth, Massachusetts, United States
• Psoriasis Treatment Center — Grand Rapids, Michigan, United States
• Woodson Clinical Studies Group, Inc. — Las Vegas, Nevada, United States
• Nashua Dermatology — Nashua, New Hampshire, United States
• Jerry Bagel — East Windsor, New Jersey, United States
• Catskill Dermatology — Monticello, New York, United States
• Marina I Peredo — Smithtown, New York, United States
• Buffalo Medical Group — Williamsville, New York, United States
• Wilmington Health Associates Dermatology — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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