The PROMiSe trial: Baseline data review and progress report

Jerry S. Wolinsky, Lorne Kastrukoff, Pierre Duquette, Mark Freedman, Paul O'Connor, Mark Debouverie, Catherine Lubetski, Gilles Edan, Etienne Roullet, Christian Confavreux, Alan Thompson, Lance Blumhardt, Stanley Hawkins, Thomas Scott, Daniel Wynn, Joana Cooper, Stephen Thurston, Stanton Elias, Clyde Markowitz, David MattsonAaron Miller, John Noseworthy, Elizabeth Shuster, Jonathan Carter, Fred Lublin, William Stuart, Michael Kaufman, Gary Birnbaum, Kottil Rammohan, Ruth Whitham, Cornelia Mihai, Steven Greenberg, Craig Smith, Mark Agius, Stan van den Noort, Lawrence Myers, James Nelson, Douglas Goodin, Barry Arnason, Khurram Bashir, Sharon Lynch

Research output: Contribution to journalArticle

53 Scopus citations

Abstract

The PROMiSe trial is a multinational, multicentre, double-blind, placebo-controlled trial evaluating the effects of glatiramer acetate treatment over 3 years in patients with primary progressive multiple sclerosis (PPMS). A total of 943 patients were enrolled, and all those remaining on-study had completed at least 24 months as of October 2002. Baseline clinical and MRI characteristics and select correlations are reported here. A total of 3.9% of patients exhibited confirmed relapse over 1904 patient-years of exposure, indicating success of efforts to exclude relapsing MS types. Of the 26.3% of patients who have prematurely withdrawn from the study, only 36% discontinued after meeting the study primary endpoint of disease progression. The progression rate in patients in the low Expanded Disability Status Scale (EDSS) stratum (3.0-5.0) observed thus far is markedly lower than the 50% annual progression rate estimate used for determining size and statistical power of the trial; progression was observed in 16.1% of patients with 12 months of study exposure. These early findings raise some concern about the ability of the trial no demonstrate a significant treatment effect, and suggest that the short-term natural history of PPMS may not be as aggressive as previously assumed.

Original languageEnglish (US)
Pages (from-to)S65-S72
JournalMultiple Sclerosis
Volume10
Issue numberSUPPL. 1
DOIs
StatePublished - Jun 2004

Keywords

  • Cerebrospinal fluid
  • Clinical trials
  • Diagnostic criteria
  • Magnetic resonance imaging
  • Primary progressive multiple sclerosis

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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  • Cite this

    Wolinsky, J. S., Kastrukoff, L., Duquette, P., Freedman, M., O'Connor, P., Debouverie, M., Lubetski, C., Edan, G., Roullet, E., Confavreux, C., Thompson, A., Blumhardt, L., Hawkins, S., Scott, T., Wynn, D., Cooper, J., Thurston, S., Elias, S., Markowitz, C., ... Lynch, S. (2004). The PROMiSe trial: Baseline data review and progress report. Multiple Sclerosis, 10(SUPPL. 1), S65-S72. https://doi.org/10.1191/1352458504ms1034oa