Safety and Tolerability of Repeat Courses of IM Alefacept

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00233662
First received: October 4, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: Alefacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.

Secondary Outcome Measures:
  • Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).

Estimated Enrollment: 400
Study Start Date: December 2002
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • At least 16 years of age.
  • Diagnosed with chronic plaque psoriasis and require systemic therapy.
  • CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).

Exclusion Criteria:

  • Unstable erthrodermic or pustular psoriasis.
  • Diagnosis of guttate psoriasis.
  • Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
  • Positive for HIV antibody.
  • Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
  • Evidence of active tuberculosis.
  • Current treatment for active tuberculosis or tuberculosis prophylaxis.
  • Female patients unwilling to practice effective contraception as defined by the investigator.
  • Female patients who are pregnant or breast-feeding.
  • Current enrollment in any other investigational drug study.
  • Previous participation in this study or previous alefacept studies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233662

  Show 46 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Barry Ticho, MD Biogen Idec
Principal Investigator: Kenneth Gordon, MD Loyola University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233662     History of Changes
Other Study ID Numbers: C-733
Study First Received: October 4, 2005
Last Updated: October 4, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014