Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
114 participants
INTERVENTIONAL
2004-07-31
2005-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Alefacept
IM
Interventions
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Alefacept
IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have had moderate, moderately severe or severe chronic plaque psoriasis as determined by the investigator prior to initial treatment (baseline) with AMEVIVE.
3. Must be 18 years of age or older.
4. Must have completed a standard 12-week course of AMEVIVE and have received at least 10 doses.
5. 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
2. Nursing mothers, pregnant women, and women planning to become pregnant
3. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
4. Treatment with another investigational drug, or approved therapy for investigational use, within 3 months of investigational drug administration.
5. 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.
6. Treatment with Ultraviolet B (UVB) phototherapy or Psoralen + Ultraviolet A (PUVA), within 4 weeks of investigational drug administration.
7. 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.
8. History of \>3 cutaneous squamous cell carcinomas or any systemic malignancy.
9. Skin lesions suspicious for malignancy.
10. Known HIV, viral hepatitis, or tuberculosis infection.
11. History of severe allergic or anaphylactic reactions.
12. ALT or AST greater than three times the upper limit of normal.
13. Significantly abnormal hematology (hemoglobin, hematocrit, platelets, white blood cells), as determined by the investigator.
14. CD4+ T lymphocyte count at screening visit less than 250 cells/mm3.
15. Known hypersensitivity to AMEVIVE or any of its components.
16. Subject's inability to comply with study requirements.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Gold
Role: PRINCIPAL_INVESTIGATOR
GoldSkin Care
Locations
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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
Robert Brodell
Warren, Ohio, United States
Dermatology & Laser Center of Roseberg
Roseburg, Oregon, United States
Dermatology Assoc of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Gold Skin Care
Nashville, Tennessee, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Texas Dermatology Research
Dallas, Texas, United States
Mark Wallis
Longview, Texas, United States
Stephen Miller
San Antonio, Texas, United States
Stephen Flax
Winchester, Virginia, United States
Dermatology & Laser Center
Bellingham, Washington, United States
Countries
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Other Identifiers
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CBT/IST 64
Identifier Type: -
Identifier Source: secondary_id
IST-US-064-04-AME
Identifier Type: -
Identifier Source: org_study_id
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