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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Moderate to Severe Chronic Plaque Psoriasis

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

16 weeks, 20 weeks or 24 weeks

Safety Issue:

No

Principal Investigator

Michael Gold

Investigator Role:

Principal Investigator

Investigator Affiliation:

GoldSkin Care

Authority:

United States: Food and Drug Administration

Study ID:

IST-US-064-04-AME

NCT ID:

NCT00168753

Start Date:

July 2004

Completion Date:

March 2005

Related Keywords:

  • Moderate to Severe Chronic Plaque Psoriasis
  • Extended dosing
  • alefacept
  • Psoriasis

Name

Location

Nashua Dermatology Nashua, New Hampshire  03062
Dermatology Associates Of Knoxville Knoxville, Tennessee  37917
Monheit Dermatology Associates Birmingham, Alabama  35203
Bayshore Dermatology Fairhope, Alabama  36532
Jayne Fortson Anchorage, Alaska  99501
Bakersfield Dermatology & Skin Cancer Medical Group Bakersfield, California  93301
Integrated Research Group Riverside, California  92501
Robert Greenberg San Ramon, California  94582
Front Dermatology Denver, Colorado  80014
Skin and Cancer Associates Tamarac, Florida  33309
Michael Scannon Tampa, Florida  33602
Atlanta Derm, Vein & Research Center Alpharetta, Georgia  30004
Pearlridge Dermatology Aiea, Hawaii  96701
Altman Dermatology Associates Arlington Heights, Illinois  60004
Calumet Dermatology Associates Calumet City, Illinois  60477
Michael Greenberg Elk Grove Village, Illinois  60007
David J. Coynik Peru, Illinois  61354
Melissa Knuckles Corbin, Kentucky  40701
Richard Eisen Plymouth, Massachusetts  02360
Psoriasis Treatment Center Grand Rapids, Michigan  49503
Woodson Clinical Studies Group, Inc. Las Vegas, Nevada  89101
Jerry Bagel East Windsor, New Jersey  08512
Catskill Dermatology Monticello, New York  12701
Marina I Peredo Smithtown, New York  11787
Buffalo Medical Group Williamsville, New York  14221
Wilmington Health Associates Dermatology Wilmington, North Carolina  28401
Robert Brodell Warren, Ohio  44481
Dermatology & Laser Center of Roseberg Roseburg, Oregon  97470
Dermatology Assoc of Plymouth Meeting Plymouth Meeting, Pennsylvania  19462
Gold Skin Care Nashville, Tennessee  37201
Bellaire Dermatology Associates Bellaire, Texas  77401
Texas Dermatology Research Dallas, Texas  75201
Mark Wallis Longview, Texas  75601
Stephen Miller San Antonio, Texas  78201
Stephen Flax Winchester, Virginia  22601
Dermatology & Laser Center Bellingham, Washington  98225