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

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ClinicalTrials.gov Identifier: NCT00692172
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Drug: Alefacept Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2001
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 1 Drug: Alefacept
intramuscular injection (IM)
Other Names:
  • Amevive
  • ASP0485




Primary Outcome Measures :
  1. Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring [ Time Frame: Throughout treatment course ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment [ Time Frame: Every 2 weeks throughout treamtent course ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692172


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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00692172     History of Changes
Other Study ID Numbers: C-728
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
psoriasis
alefacept
intramuscular

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents