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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 DermatologyNashua, New Hampshire  03062
Dermatology Associates Of KnoxvilleKnoxville, Tennessee  37917
Monheit Dermatology AssociatesBirmingham, Alabama  35203
Bayshore DermatologyFairhope, Alabama  36532
Jayne FortsonAnchorage, Alaska  99501
Bakersfield Dermatology & Skin Cancer Medical GroupBakersfield, California  93301
Integrated Research GroupRiverside, California  92501
Robert GreenbergSan Ramon, California  94582
Front DermatologyDenver, Colorado  80014
Skin and Cancer AssociatesTamarac, Florida  33309
Michael ScannonTampa, Florida  33602
Atlanta Derm, Vein & Research CenterAlpharetta, Georgia  30004
Pearlridge DermatologyAiea, Hawaii  96701
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Calumet Dermatology AssociatesCalumet City, Illinois  60477
Michael GreenbergElk Grove Village, Illinois  60007
David J. CoynikPeru, Illinois  61354
Melissa KnucklesCorbin, Kentucky  40701
Richard EisenPlymouth, Massachusetts  02360
Psoriasis Treatment CenterGrand Rapids, Michigan  49503
Woodson Clinical Studies Group, Inc.Las Vegas, Nevada  89101
Jerry BagelEast Windsor, New Jersey  08512
Catskill DermatologyMonticello, New York  12701
Marina I PeredoSmithtown, New York  11787
Buffalo Medical GroupWilliamsville, New York  14221
Wilmington Health Associates DermatologyWilmington, North Carolina  28401
Robert BrodellWarren, Ohio  44481
Dermatology & Laser Center of RosebergRoseburg, Oregon  97470
Dermatology Assoc of Plymouth MeetingPlymouth Meeting, Pennsylvania  19462
Gold Skin CareNashville, Tennessee  37201
Bellaire Dermatology AssociatesBellaire, Texas  77401
Texas Dermatology ResearchDallas, Texas  75201
Mark WallisLongview, Texas  75601
Stephen MillerSan Antonio, Texas  78201
Stephen FlaxWinchester, Virginia  22601
Dermatology & Laser CenterBellingham, Washington  98225