A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

CompletadoFase 3ClinicalTrials.gov

ID: NCT03599245Tipo: INTERVENTIONALInicio: 12 de jul de 2018Fin estimado: 17 de jul de 2025

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Resumen

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

Descripción detallada

This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Signed Informed Consent Form
Able to comply with the study protocol, in the investigator's judgment
Completed the treatment period of Roche sponsored ocrelizumab P-trials

Criterios de exclusión

Hypersensitivity to ocrelizumab or to any of its excipients.
Participantss in a severely immunocompromised state until the condition resolves.
Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
Existence of a contra-indication as per SmPC
Prohibited concomitant medication as specified in protocol
Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

Intervenciones

drug

Ocrelizumab

Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.

Ubicaciones

Hospital Churruca Visca

Buenos Aires, Argentina

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Rosarina de Neurorehabilitacion

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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