Community Based Trial for AMEVIVE®
- Registration Number
- NCT00168753
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Alefacept -
- Primary Outcome Measures
Name Time Method To evaluate the safety of treating subjects with up to 12 additional doses of alefacept 15 mg IM following a standard 12-week course of AMEVIVE. 16 weeks, 20 weeks or 24 weeks
- Secondary Outcome Measures
Name Time Method The cumulative change in PQA score from screening visit to best PQA score at any time in the study, End of study The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, End of study Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively. End of study The cumulative change in SSA score from screening visit to best SSA score at any time in the study, End of study Time to re-treatment for subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study, End of study Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study, End of study Association of the total number of doses received with the best efficacy reached, as assessed by SSA score, at any time during the study, and End of study
Trial Locations
- Locations (36)
Michael Scannon
🇺🇸Tampa, Florida, United States
Calumet Dermatology Associates
🇺🇸Calumet City, Illinois, United States
Skin and Cancer Associates
🇺🇸Tamarac, Florida, United States
Buffalo Medical Group
🇺🇸Williamsville, New York, United States
Richard Eisen
🇺🇸Plymouth, Massachusetts, United States
Dermatology & Laser Center of Roseberg
🇺🇸Roseburg, Oregon, United States
Gold Skin Care
🇺🇸Nashville, Tennessee, United States
Woodson Clinical Studies Group, Inc.
🇺🇸Las Vegas, Nevada, United States
Jayne Fortson
🇺🇸Anchorage, Alaska, United States
Dermatology Associates of Knoxville
🇺🇸Knoxville, Tennessee, United States
Stephen Miller
🇺🇸San Antonio, Texas, United States
Pearlridge Dermatology
🇺🇸Aiea, Hawaii, United States
Bayshore Dermatology
🇺🇸Fairhope, Alabama, 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
Atlanta Derm, Vein & Research Center
🇺🇸Alpharetta, Georgia, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Stephen Flax
🇺🇸Winchester, Virginia, United States
Michael Greenberg
🇺🇸Elk Grove Village, Illinois, United States
David J. Coynik
🇺🇸Peru, Illinois, United States
Melissa Knuckles
🇺🇸Corbin, Kentucky, United States
Catskill Dermatology
🇺🇸Monticello, New York, United States
Wilmington Health Associates Dermatology
🇺🇸Wilmington, North Carolina, United States
Robert Brodell
🇺🇸Warren, Ohio, United States
Marina I Peredo
🇺🇸Smithtown, New York, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Mark Wallis
🇺🇸Longview, Texas, United States
Dermatology & Laser Center
🇺🇸Bellingham, Washington, United States
Texas Dermatology Research
🇺🇸Dallas, Texas, United States
Monheit Dermatology Associates
🇺🇸Birmingham, Alabama, United States
Front Dermatology
🇺🇸Denver, Colorado, United States
Nashua Dermatology
🇺🇸Nashua, New Hampshire, United States
Jerry Bagel
🇺🇸East Windsor, New Jersey, United States
Psoriasis Treatment Center
🇺🇸Grand Rapids, Michigan, United States
Dermatology Assoc of Plymouth Meeting
🇺🇸Plymouth Meeting, Pennsylvania, United States