This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
- Registration Number
- NCT03599245
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
- Primary Outcome Measures
Name Time Method Mean change from inclusion in parent study in EDSS score over the course of the treatment Up to 2 years Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks Up to 2 Years Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment Up to 2 years Percentage of participants who have improved, stable or worsened disability compared with baseline Up to 2 years Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is \> 0.5 increase of EDSS, Improvement is \>0.5 decrease of EDSS
Time to 20% increase in timed 25-foot walk test (T25FWT) Up to 2 years Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment
- Secondary Outcome Measures
Name Time Method Time to first protocol-defined event of disease activity Up to 2 Years Time to first relapse Up to 2 Years Annualized relapse rate Up to 2 Years Percentage of participants relapse free, yearly and over the course of the treatment Up to 2 Years Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment Up to 2 Years Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI).
Percentage of participants with no evidence of progression (NEP) Up to 2 Years NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment
Presence and evolution of leptomeningeal follicles as detected by MRI Up to 2 Years Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD) Up to 2 Years NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT) Up to 2 Years Total number of T1 Gd-enhancing lesions as detected by brain MRI over time Up to 2 Years Total number of new and/or enlarging T2 lesion as detected by brain MRI over time Up to 2 Years Change in total T1 hypointense lesion volume over time Up to 2 Years Participant reported outcomes: SymptoMScreen Score Up to 2 Years Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29) Up to 2 Years Percentage of Participants with Adverse Events Up to 2 Years Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time Up to 2 Years Change in brain volume (grey and white matter) as detected by brain MRI over time Up to 2 Years Time to treatment discontinuation/switch Up to 2 Years Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI]) Up to 2 Years Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period Up to 2 years
Trial Locations
- Locations (157)
Hospital Churruca Visca
🇦🇷Buenos Aires, Argentina
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Fundacion Rosarina de Neurorehabilitacion
🇦🇷Rosario, Argentina
AZ Sint Jan
🇧🇪Brugge, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
CHU Tivoli
🇧🇪La Louvière, Belgium
CHU Sart-Tilman
🇧🇪Liège, Belgium
Revalidatie en MS Centrum
🇧🇪Overpelt, Belgium
Instituto de Neurologia de Curitiba
🇧🇷Curitiba, Paraná, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
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