A phase II trial of anti-CD4 antibodies in the treatment of multiple sclerosis
vanOosten, BW; Lai, M; Barkhof, F; Miller, DH; Moseley, IF; Thompson, AJ; Hodgkinson, S; Polman, CH; vanOosten, BW, Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands; Lai, M, The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK; Barkhof, F, Department of Diagnostic Radiology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands; Miller, DH, The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK; Moseley, IF, Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands; Thompson, AJ, The National Hospital Institute of Neurology, Queen Square, London WC1N 3BG, UK; Hodgkinson, S, Department of Neurology, Liverpool Hospital, University of New South Wales, PO Box 103, Liverpool NSW 2170, Australia; Polman, CH, Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB, Amsterdam, The Netherlands
Журнал:
Multiple Sclerosis
Дата:
1996
Аннотация:
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.
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