Clinical trial NCT00168753: Community Based Trial for AMEVIVE®
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: Extended dosing
alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2005-09-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Must give written informed consent.
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:

1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or not willing to practice effective contraception during the study.
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.

Primary outcomes:
measure: 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.
timeFrame: 16 weeks, 20 weeks or 24 weeks
Secondary outcomes:
measure: The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,
timeFrame: End of study
measure: The cumulative change in PQA score from screening visit to best PQA score at any time in the study,
timeFrame: End of study
measure: Association of the total number of doses received with the best efficacy reached, as assessed by PQA score, at any time during the study,
timeFrame: End of study
measure: 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,
timeFrame: End of study
measure: The cumulative change in SSA score from screening visit to best SSA score at any time in the study,
timeFrame: End of study
measure: 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
timeFrame: End of study
measure: Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.
timeFrame: End of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Monheit Dermatology Associates
state: Alabama
city: Fairhope
country: United States
facility: Bayshore Dermatology
state: Alabama
city: Anchorage
country: United States
facility: Jayne Fortson
state: Alaska
city: Bakersfield
country: United States
facility: Bakersfield Dermatology & Skin Cancer Medical Group
state: California
city: Riverside
country: United States
facility: Integrated Research Group
state: California
city: San Ramon
country: United States
facility: Robert Greenberg
state: California
city: Denver
country: United States
facility: Front Dermatology
state: Colorado
city: Tamarac
country: United States
facility: Skin and Cancer Associates
state: Florida
city: Tampa
country: United States
facility: Michael Scannon
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Derm, Vein & Research Center
state: Georgia
city: Aiea
country: United States
facility: Pearlridge Dermatology
state: Hawaii
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Calumet City
country: United States
facility: Calumet Dermatology Associates
state: Illinois
city: Elk Grove Village
country: United States
facility: Michael Greenberg
state: Illinois
city: Peru
country: United States
facility: David J. Coynik
state: Illinois
city: Corbin
country: United States
facility: Melissa Knuckles
state: Kentucky
city: Plymouth
country: United States
facility: Richard Eisen
state: Massachusetts
city: Grand Rapids
country: United States
facility: Psoriasis Treatment Center
state: Michigan
city: Las Vegas
country: United States
facility: Woodson Clinical Studies Group, Inc.
state: Nevada
city: Nashua
country: United States
facility: Nashua Dermatology
state: New Hampshire
city: East Windsor
country: United States
facility: Jerry Bagel
state: New Jersey
city: Monticello
country: United States
facility: Catskill Dermatology
state: New York
city: Smithtown
country: United States
facility: Marina I Peredo
state: New York
city: Williamsville
country: United States
facility: Buffalo Medical Group
state: New York
city: Wilmington
country: United States
facility: Wilmington Health Associates Dermatology
state: North Carolina
city: Warren
country: United States
facility: Robert Brodell
state: Ohio
city: Roseburg
country: United States
facility: Dermatology & Laser Center of Roseberg
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Assoc of Plymouth Meeting
state: Pennsylvania
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Gold Skin Care
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Texas Dermatology Research
state: Texas
city: Longview
country: United States
facility: Mark Wallis
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller
state: Texas
city: Winchester
country: United States
facility: Stephen Flax
state: Virginia
city: Bellingham
country: United States
facility: Dermatology & Laser Center
state: Washington
Study officials:
affiliation: GoldSkin Care
name: Michael Gold
role: PRINCIPAL_INVESTIGATOR
References: