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 (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00692172
First received: June 4, 2008
Last updated: September 17, 2014
Last verified: September 2014
  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
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: NCT00692172

  Hide Study Locations
Locations
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Fresno, California, United States, 93710
La Jolla, California, United States, 92037
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Jacksonville, Florida, United States, 32204
Pinellas Park, Florida, United States, 33781
United States, Georgia
Newnan, Georgia, United States, 30263
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Michigan
Clinton Township, Michigan, United States, 48038
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, Oregon
Lake Oswego, Oregon, United States, 79035
Portland, Oregon, United States, 97210
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Austin, Texas, United States, 78759
San Antonio, Texas, United States, 78229
Belgium
Brussels, Belgium, B-1070
Edegem, Belgium, B-2650
Liege, Belgium, 4000
Canada, Alberta
Calgary, Alberta, Canada, T2S 3B3
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C ON2
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 4S8
Canada, Ontario
London, Ontario, Canada, N6A 3H7
Waterloo, Ontario, Canada, N2J 1C
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Sainte-Foy, Quebec, Canada, G1V 4X7
Denmark
Copenhagen, Denmark, DK-2400
France
Besancon, France, 25030
Brest, France, 29279
Nice, France, 06202
Paris, France, 75475
Tours, France, 37044
Germany
Bochum, Germany, 44791
Dresden, Germany, 01307
Munich, Germany, 80337
Netherlands
Amsterdam, Netherlands, 1100 DE
Spain
Madrid, Spain, 28006
Valencia, Spain, 46014
United Kingdom
Liverpool, United Kingdom, L14 3LB
Sponsors and Collaborators
Astellas Pharma Inc
Biogen Idec
Investigators
Study Director: Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00692172     History of Changes
Other Study ID Numbers: C-728
Study First Received: June 4, 2008
Last Updated: September 17, 2014
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 October 01, 2014