A Randomized, Double-Blind (With Respect To Ocrelizumab Dose) And Rater-Blind (Versus Comparator), Parallel-Group Study To Evaluate The Efficacy And Safety Of Two Doses Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis

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Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2011
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This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.
Epistemonikos ID: edb40580d096be1c6d148d3d3abce8d91a413885
First added on: Aug 10, 2018