Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Jun 16;94(24):1088-1092.
doi: 10.1212/WNL.0000000000009636. Epub 2020 May 29.

The 2013 clinical course descriptors for multiple sclerosis: A clarification

Collaborators, Affiliations
Review

The 2013 clinical course descriptors for multiple sclerosis: A clarification

Fred D Lublin et al. Neurology. .

Erratum in

Abstract

The clinical courses of multiple sclerosis were defined in 1996 and refined in 2013 to provide a time-based assessment of the current status of the individual. These definitions have been successfully used by clinicians, clinical trialists, and regulatory authorities. Recent regulatory decisions produced variations and discrepancies in the use of the clinical course descriptions. We provide here a clarification of the concepts underlying these descriptions and restate the principles used in their development. Importantly, we highlight the critical importance of time framing the disease course modifiers activity and progression and clarify the difference between the terms worsening and progressing.

PubMed Disclaimer

References

    1. Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National multiple sclerosis society (USA) advisory committee on clinical trials of new agents in multiple sclerosis. Neurology 1996;46:907–911. - PubMed
    1. Lublin FD, Reingold SC, Cohen JA, et al. . Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology 2014;83:278–286. - PMC - PubMed
    1. Food and Drug Administration (USA). Ocrelizumab Summary Review; 2017. Available at: accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000SumR.pdf. Accessed November 23, 2019.
    1. European Medicines Agency. Summary of Opinion—Ocrevus; 2017. Available at: ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-oc.... Accessed September 23, 2019.
    1. European Medicines Agency. Summary of Opinion—Mayzent; 2019. Available at: ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ma.... Accessed September 23, 2019.

Publication types