Community Based Trial for AMEVIVE®
An Open-Label Community-Based Study to Determine the Safety and Efficacy of an Extended Course of Alefacept, Following a Standard 12-Week Course of Amevive®, With Commonly Used Clinical Assessment Tools
2 other identifiers
interventional
114
1 country
36
Brief Summary
To evaluate the safety of treating subjects with up to 12 additional doses of alefacept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2004
Shorter than P25 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedSeptember 8, 2014
September 1, 2014
8 months
September 13, 2005
September 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
The cumulative change in PQA score from screening visit to best PQA score at any time in 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
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
The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
End of study
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Biogencollaborator
Study Sites (36)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Gold
GoldSkin Care
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
July 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
September 8, 2014
Record last verified: 2014-09