Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00692172
First received: June 4, 2008
Last updated: November 3, 2010
Last verified: June 2008
  Purpose

An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.


Condition Intervention Phase
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, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring [ Time Frame: Throughout treatment course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment [ Time Frame: Every 2 weeks throughout treamtent course ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: December 2001
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Alefacept
intramuscular injection (IM)
Other Names:
  • Amevive
  • ASP0485

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
  • Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728

Exclusion Criteria:

  • Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
  • Clinically significant abnormal hematology values or history of an immunosuppressive disorder
  • Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
  • A significant change in the subject's medical history from their previous alefacept study
  • Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
  • Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692172

  Show 43 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Biogen Idec
Investigators
Study Director: Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00692172     History of Changes
Other Study ID Numbers: C-728
Study First Received: June 4, 2008
Last Updated: November 3, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Canada: Health Canada
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
psoriasis
alefacept
intramuscular

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

ClinicalTrials.gov processed this record on April 23, 2014