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