BENITIONSClinical Trial Intelligence

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

3期 进行中(已停止招募) NCT05123703

适应症Relapsing-remitting Multiple Sclerosis
分期3期
申办方Hoffmann-La Roche
状态进行中(已停止招募)
受试者人数188 人
干预(药物)Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo
开始日期2022年5月19日
完成日期2025年6月9日
结果公布日2026年7月15日

摘要

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.

Protocol-defined Annualized Relapse Rate (ARR)

Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks) · relapses per patient-year

Ocrelizumab0.070 relapses per patient-year
Fingolimod0.135 relapses per patient-year
Adjusted Rate Ratio0.517 (95% CI 0.193–1.329)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。