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  • Updated 02.13.2023
  • Released 11.12.2002
  • Expires For CME 02.13.2026

Clinical trials in multiple sclerosis



In this article, the authors review the basics of multiple sclerosis clinical trial design as well as current data on the treatment of relapses and FDA-approved disease-modifying therapies, including therapies indicated for relapsing and progressive disease.

Key points

• There are currently 20 FDA-approved disease-modifying therapies available for the treatment of relapsing-remitting multiple sclerosis.

• More recent approvals for relapsing-remitting multiple sclerosis have included the oral therapies monomethyl fumarate, ozanimod, and ponesimod and the subcutaneous injection, ofatumumab.

• Ublituximab, a novel anti-CD20 disease-modifying therapy, was approved for relapsing-remitting multiple sclerosis by the FDA in late 2022 and is on the market as of 2023.

• The first clinical trial for the treatment of radiologically isolated syndrome (with dimethyl fumarate) was reported in 2022.

• Treatment of progressive disease remains challenging, with limited options. Only ocrelizumab is approved for primary progressive multiple sclerosis.

• BTK inhibitors are the most active area of current therapeutic development, with multiple ongoing phase III trials for both progressive and relapsing disease.

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ISSN: 2831-9125