This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by vanOosten, B. Articles by Polman, C. Search for Related Content PubMed Articles by vanOosten, B. Articles by Polman, C. Social Bookmarking                         What's this?

A phase II trial of anti-CD4 antibodies in the treatment of multiple sclerosis

Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands

M Lai

The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK

F Barkhof

Department of Diagnostic Radiology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands

DH Miller

The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK

IF Moseley

Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands

AJ Thompson

The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK

S Hodgkinson

Department of Neurology, Liverpool Hospital, University of New South Wales, PO Box 103, Liverpool NSW 2170, Australia

CH Polman

Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands

In multiple sclerosis (MS) myelin damage is the result of a chronic inflammatory process mediated by CD4 positive T helper/effector cells. In experimental allergic encephalomyelitis (EAE), the animal model of MS, treatment with anti-CD4 antibodies can prevent the onset of disease. Natural history studies have demonstrated that gadolinium enhanced magnetic resonance imaging (MRI) of the brain is more sensitive and objective in assessing inflammatory disease activity in MS than clinical monitoring, so that less patients and shorter studies suffice to reach the same statistical power as compared to trials using clinical outcome parameters. In this paper we describe the design of an exploratory trial of chimeric monoclonal anti-CD4 antibodies in the treatment of MS. For this study we chose the number of active MS lesions on monthly gadolinium enhanced MRI scans as the primary outcome measure.

Key Words: multiple sclerosis • anti-CD4 antibodies • treatment • magnetic resonance imaging • trial design

Multiple Sclerosis, Vol. 1, No. 6, 339-342 (1996)
DOI: 10.1177/135245859600100611


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?