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Safety and Tolerability of Repeat Courses of IM Alefacept

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ClinicalTrials.gov Identifier: NCT00794807
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : November 20, 2008
Sponsor:
Collaborator:
Biogen
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Alefacept Phase 4

Detailed Description:
Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis
Study Start Date : February 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Alefacept Drug: Alefacept
Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.
Other Name: LFA-3/IgG1 fusion protein




Primary Outcome Measures :
  1. Safety of an extended courses of alefacept when administered to subjects with chronic plaque psoriasis. Safety parameters: Physical examinations; vital signs; infections; blood test: lymphocyte subset analysis (CD4+); and adverse events. [ Time Frame: 12 + 4 weeks ]

Secondary Outcome Measures :
  1. Efficacy of an extended course of alefacept when administered to subjects with chronic plaque psoriasis: Time to requirement of additional systemic therapies, Psoriasis Area and Severity Index (PASI); Physician Global Assessment (PGA). [ Time Frame: 12 + 4 weeks ]


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:

  1. Must give written informed consent.
  2. Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.

Exclusion Criteria:

  1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  2. 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).
  3. Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
  4. Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
  5. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
  6. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
  7. Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
  8. Known HIV+, known viral Hepatitis infection, known tuberculosis infection.

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): NCT00794807


Locations
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Germany
Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Biogen
Investigators
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Study Director: Wolfram Sterry, Prof. M.D. Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin

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Responsible Party: Prof. W. Sterry, Dr. S. Philipp, Department of Dermatology and Allergy, Charite University
ClinicalTrials.gov Identifier: NCT00794807     History of Changes
Other Study ID Numbers: A Study of an Extended Regimen
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: November 2008
Keywords provided by Charite University, Berlin, Germany:
Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamos
Therapeutic Uses
Dermatologic Agents
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents