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Safety and Tolerability of Repeat Courses of IM Alefacept

NCT00794807 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-11-20

No results posted yet for this study

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.

Conditions

  • Chronic Plaque Psoriasis

Interventions

DRUG

Alefacept

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

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Wolfram Sterry, Prof. M.D. · Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794807 on ClinicalTrials.gov