Psoriasis Clinical Trial
Community Based Trial for AMEVIVE®
Summary
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Full Description
Male and female subjects at least 18 years of age with moderate to severe plaque psoriasis treated with 12 weeks of alefacept 15 mg IM and who have not achieved the desired response.
Dosing Groups: Subjects will receive either 4, 8, or 12 doses of alefacept 15 mg IM weekly immediately (within 14 days) following a standard 12-dose course of AMEVIVE® 15 mg IM. Determination of number of doses will be based on physician qualitative assessment at weeks 4 and 8.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 36 Locations for this study
Birmingham Alabama, 35203, United States
Fairhope Alabama, 36532, United States
Anchorage Alaska, 99501, United States
Bakersfield California, 93301, United States
Riverside California, 92501, United States
San Ramon California, 94582, United States
Denver Colorado, 80014, United States
Tamarac Florida, 33309, United States
Tampa Florida, 33602, United States
Alpharetta Georgia, 30004, United States
Aiea Hawaii, 96701, United States
Arlington Heights Illinois, 60004, United States
Calumet City Illinois, 60477, United States
Elk Grove Village Illinois, 60007, United States
Peru Illinois, 61354, United States
Corbin Kentucky, 40701, United States
Plymouth Massachusetts, 02360, United States
Grand Rapids Michigan, 49503, United States
Las Vegas Nevada, 89101, United States
Nashua New Hampshire, 03060, United States
East Windsor New Jersey, 08512, United States
Monticello New York, 12701, United States
Smithtown New York, 11787, United States
Williamsville New York, 14221, United States
Wilmington North Carolina, 28401, United States
Warren Ohio, 44481, United States
Roseburg Oregon, 97470, United States
Plymouth Meeting Pennsylvania, 19462, United States
Knoxville Tennessee, 37902, United States
Nashville Tennessee, 37201, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75201, United States
Longview Texas, 75601, United States
San Antonio Texas, 78201, United States
Winchester Virginia, 22601, United States
Bellingham Washington, 98225, United States
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