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

Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2011

Este artículo no está incluido en ninguna revisión sistemática

Este artículo es parte de los siguientes hilos de publicación
Cargando información sobre las referencias
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