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 |
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| 分期 | 3期 |
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| 申办方 | Hoffmann-La Roche |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 188 人 |
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| 干预(药物) | Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo |
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| 开始日期 | 2022年5月19日 |
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| 完成日期 | 2025年6月9日 |
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| 结果公布日 | 2026年7月15日 |
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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
| Ocrelizumab | 0.070 relapses per patient-year |
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| Fingolimod | 0.135 relapses per patient-year |
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| Adjusted Rate Ratio | 0.517 (95% CI 0.193–1.329) |
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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。