Active — Not RecruitingPhase 3

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

United States188 participantsStarted 2022-05-19

Plain-language summary

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.

Who can participate

Age range10 Years – 17 Years

SexALL

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Inclusion criteria

✓Participants in Group A (ocrelizumab in the double-blind period \[DBP\]) and Group B (fingolimod in the DBP) who, in the opinion of the investigator, may benefit from switching to ocrelizumab and who have completed the DBP with study treatment (ocrelizumab/fingolimod), may participate in the OLE period

Exclusion criteria

✕Participants who have discontinued the study during the DBP

What they're measuring

Annualized Relapse Rate (ARR)

Timeframe: Baseline up to approximately 4 years

Trial details

NCT IDNCT05123703

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-09

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