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Safety and Tolerability of Repeat Courses of IM Alefacept

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00794807
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Plaque Psoriasis
Drug: Alefacept
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alefacept Drug: Alefacept
Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.
Other Name: LFA-3/IgG1 fusion protein

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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00794807

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

No publications provided

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
Study First Received: November 19, 2008
Last Updated: November 19, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamos
Therapeutic Uses
Dermatologic Agents

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

ClinicalTrials.gov processed this record on November 20, 2014