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Safety and Tolerability of Repeat Courses of IM Alefacept

NCT ID: NCT00794807

Last Updated: 2008-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Chronic Plaque Psoriasis

Keywords

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Alefacept Skin Diseases Psoriasis Skin Diseases, Papulosquamos Therapeutic Uses Dermatologic Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alefacept

Group Type EXPERIMENTAL

Alefacept

Intervention Type DRUG

Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.

Interventions

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Alefacept

Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.

Intervention Type DRUG

Other Intervention Names

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LFA-3/IgG1 fusion protein

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Department of Dermatology and Allergy, Charite University

Principal Investigators

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Wolfram Sterry, Prof. M.D.

Role: STUDY_DIRECTOR

Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin

Locations

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Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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A Study of an Extended Regimen

Identifier Type: -

Identifier Source: org_study_id