Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

  • STATUS
    Not Recruiting
  • participants needed
    900
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 May 2021

Summary

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

Description

This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multicenter study with variable treatment duration in approximately 900 patients with relapsing MS. The maximal treatment duration in the study for an individual patient will be 2.5 years.

Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous (sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Details
Condition Relapsing Multiple Scelrosis
Treatment Ofatumumab subcutaneous injection, Placebo orally matching to teriflunomide, Teriflunomide orally, Placebo subcutaneous injection matching to ofatumumab
Clinical Study IdentifierNCT02792231
SponsorNovartis Pharmaceuticals
Last Modified on19 May 2021

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