Validation of MRI Surrogates

  • M. P. Sormani
  • M. Filippi
Part of the Topics in Neuroscience book series (TOPNEURO)


Traditionally, the clinical endpoints used to monitor clinical trials in multiple sclerosis (MS) are the occurrence of relapses (usually expressed as a rate over time), and the degree of disability, most commonly evaluated using the Expanded Disability Status Scale (EDSS) [1].


Multiple Sclerosis Expand Disability Status Scale Secondary Progressive Multiple Sclerosis Baseline Expand Disability Status Scale Secondary Progressive Multiple Sclerosis Patient 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Kurtzke JF (1983) Rating neurological impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33:1444–1452PubMedGoogle Scholar
  2. 2.
    McFarland H, Barkhof F, Antel J, Miller DH (2002) The role of MRI as a surrogate outcome measure in MS. Mult Scler 8:40–51PubMedCrossRefGoogle Scholar
  3. 3.
    Prentice RL (1989) Surrogate markers in clinical trials: definition and operational criteria. Stat Med 8:431–440PubMedCrossRefGoogle Scholar
  4. 4.
    Sormani MP, Bruzzi P, Comi GC, Filippi M (2002) MRI metrics as surrogate markers for clinical relapse rate in relapsing remitting MS patients. Neurology 58:417–421PubMedGoogle Scholar
  5. 5.
    Sormani MP, Bruzzi P, Beckmann K et al (2003) MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFNβ-lb. Neurology 60:1462–1466PubMedGoogle Scholar
  6. 6.
    Comi G, Filippi M, Wolinsky JS and the European/Canadian Glatiramer Acetate Study Group (2001) European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 49:290–297PubMedCrossRefGoogle Scholar
  7. 7.
    Kappos L, Polman C, Pozzilli C et al (2001) Final analysis of the European multicenter trial on IFNβ-lb in secondary-progressive MS. Neurology 57:1969–1975PubMedGoogle Scholar
  8. 8.
    Li DKB, Zhao GJ, Paty DW and the University of British Columbia MS/MRI Analysis Research Group and the SPECTRIMS Study Group (2001) Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology 56:1505–1513PubMedGoogle Scholar
  9. 9.
    Cohen JA, Citter GR, Goodman DA et al (2002) Benefit of interferon β-la on MSFC progression in secondary progressive MS. Neurology 59:679–687PubMedGoogle Scholar
  10. 10.
    Panitch H, Miller A, Paty D, Weinshenker B for the North American Study Group on Interferon beta-1b in Secondary Progressive MS (2004) Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 63:1788–1795PubMedGoogle Scholar

Copyright information

© Springer-Verlag Italia 2007

Authors and Affiliations

  • M. P. Sormani
    • 1
  • M. Filippi
    • 2
  1. 1.Biostatistics Unit Department of Health Sciences (DISSAL)University of GenovaGenoaItaly
  2. 2.Neuroimaging Research Unit Department of NeurologyScientific Institute and University Ospedale San RaffaeleMilanItaly

Personalised recommendations