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Community Based Trial for AMEVIVE®

Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Severe Chronic Plaque Psoriasis

Intervention: Alefacept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Michael Gold, Principal Investigator, Affiliation: GoldSkin Care

Summary

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

Clinical Details

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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

The proportion of subjects who achieve moderate improvement, significant improvement or clear, as assessed by the PQA score, at any time during the study,

The cumulative change in PQA score from screening visit to best PQA score at any time in the 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,

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,

The cumulative change in SSA score from screening visit to best SSA score at any time in the 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

Association of subject assessment of efficacy with physician assessment of efficacy as measured by the SSA score and PQA score respectively.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Bayshore Dermatology, Fairhope, Alabama 36532, United States

Monheit Dermatology Associates, Birmingham, Alabama 35203, United States

Jayne Fortson, Anchorage, Alaska 99501, United States

Bakersfield Dermatology & Skin Cancer Medical Group, Bakersfield, California 93301, United States

Robert Greenberg, San Ramon, California 94582, United States

Integrated Research Group, Riverside, California 92501, 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

David J. Coynik, Peru, Illinois 61354, United States

Michael Greenberg, Elk Grove Village, Illinois 60007, United States

Calumet Dermatology Associates, Calumet City, Illinois 60477, 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

Buffalo Medical Group, Williamsville, New York 14221, United States

Marina I Peredo, Smithtown, New York 11787, 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

Gold Skin Care, Nashville, Tennessee 37201, United States

Dermatology Associates of Knoxville, Knoxville, Tennessee 37902, United States

Texas Dermatology Research, Dallas, Texas 75201, United States

Stephen Miller, San Antonio, Texas 78201, United States

Bellaire Dermatology Associates, Bellaire, Texas 77401, United States

Mark Wallis, Longview, Texas 75601, United States

Stephen Flax, Winchester, Virginia 22601, United States

Dermatology & Laser Center, Bellingham, Washington 98225, United States

Additional Information

Starting date: July 2004
Ending date: March 2005
Last updated: March 29, 2008

Page last updated: June 20, 2008

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