Psoriasis Clinical Trial

Community Based Trial for AMEVIVE®

Summary

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

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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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

114

Study ID:

NCT00168753

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 36 Locations for this study

See Locations Near You

Monheit Dermatology Associates
Birmingham Alabama, 35203, United States
Bayshore Dermatology
Fairhope Alabama, 36532, United States
Jayne Fortson
Anchorage Alaska, 99501, United States
Bakersfield Dermatology & Skin Cancer Medical Group
Bakersfield California, 93301, United States
Integrated Research Group
Riverside California, 92501, United States
Robert Greenberg
San Ramon California, 94582, United States
Front Dermatology
Denver Colorado, 80014, United States
Skin and Cancer Associates
Tamarac Florida, 33309, United States
Michael Scannon
Tampa Florida, 33602, United States
Atlanta Derm, Vein & Research Center
Alpharetta Georgia, 30004, United States
Pearlridge Dermatology
Aiea Hawaii, 96701, United States
Altman Dermatology Associates
Arlington Heights Illinois, 60004, United States
Calumet Dermatology Associates
Calumet City Illinois, 60477, United States
Michael Greenberg
Elk Grove Village Illinois, 60007, United States
David J. Coynik
Peru Illinois, 61354, United States
Melissa Knuckles
Corbin Kentucky, 40701, United States
Richard Eisen
Plymouth Massachusetts, 02360, United States
Psoriasis Treatment Center
Grand Rapids Michigan, 49503, United States
Woodson Clinical Studies Group, Inc.
Las Vegas Nevada, 89101, United States
Nashua Dermatology
Nashua New Hampshire, 03060, United States
Jerry Bagel
East Windsor New Jersey, 08512, United States
Catskill Dermatology
Monticello New York, 12701, United States
Marina I Peredo
Smithtown New York, 11787, United States
Buffalo Medical Group
Williamsville New York, 14221, United States
Wilmington Health Associates Dermatology
Wilmington North Carolina, 28401, United States
Robert Brodell
Warren Ohio, 44481, United States
Dermatology & Laser Center of Roseberg
Roseburg Oregon, 97470, United States
Dermatology Assoc of Plymouth Meeting
Plymouth Meeting Pennsylvania, 19462, United States
Dermatology Associates of Knoxville
Knoxville Tennessee, 37902, United States
Gold Skin Care
Nashville Tennessee, 37201, United States
Bellaire Dermatology Associates
Bellaire Texas, 77401, United States
Texas Dermatology Research
Dallas Texas, 75201, United States
Mark Wallis
Longview Texas, 75601, United States
Stephen Miller
San Antonio Texas, 78201, United States
Stephen Flax
Winchester Virginia, 22601, United States
Dermatology & Laser Center
Bellingham Washington, 98225, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

114

Study ID:

NCT00168753

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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