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Active Not Recruiting NCT05123703

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

Conditions: Relapsing-remitting Multiple Sclerosis

Sex: All
Ages: 10 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 188
Sponsor: Hoffmann-La Roche

Location: UC San Diego La Jolla California

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.

Eligibility Criteria

Inclusion Criteria: * Body weight ≥ 25 kg * Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric multiple sclerosis (MS), Version 2012, or McDonald criteria 2017 * Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive * For all countries except Germany, at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd-enhancing lesion on MRI within 6 months prior to randomization Inclusion Criteria for Optional OLE Period: -Participants in Group A (ocrelizumab in the 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: * Known presence or suspicion of other neurologic disorders that may mimic MS * Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude participant from participating in the study * Participants with severe cardiac disease or significant findings on the screening electrocardiograph (ECG) Exclusion Criteria for Optional OLE Period: -Participants who have discontinued the study during the DBP

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05123703). StuddyBuddy aggregates publicly available trial information.