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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,055
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
Time frame: 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
Time frame: Up to 2 years
Percentage of participants who have improved, stable or worsened disability compared with baseline
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 frame: Up to 2 years
Mean change from inclusion in parent study in EDSS score over the course of the treatment
Time frame: Up to 2 years
Time to 20% increase in timed 25-foot walk test (T25FWT)
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
Time frame: Up to 2 years
Time to first protocol-defined event of disease activity
Time frame: Up to 2 Years
Time to first relapse
Time frame: Up to 2 Years
Annualized relapse rate
Time frame: Up to 2 Years
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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
Bruges, Belgium
UZ Antwerpen
Edegem, Belgium
CHU Tivoli
La Louvière, Belgium
CHU de Liège (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
...and 149 more locations
Percentage of participants relapse free, yearly and over the course of the treatment
Time frame: Up to 2 Years
Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment
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).
Time frame: Up to 2 Years
Percentage of participants with no evidence of progression (NEP)
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
Time frame: Up to 2 Years
Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)
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
Time frame: Up to 2 Years
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
Time frame: Up to 2 Years
Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
Time frame: Up to 2 Years
Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
Time frame: Up to 2 Years
Change in total T1 hypointense lesion volume over time
Time frame: Up to 2 Years
Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time
Time frame: Up to 2 Years
Change in brain volume (grey and white matter) as detected by brain MRI over time
Time frame: Up to 2 Years
Presence and evolution of leptomeningeal follicles as detected by MRI
Time frame: Up to 2 Years
Time to treatment discontinuation/switch
Time frame: Up to 2 Years
Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
Time frame: Up to 2 Years
Participant reported outcomes: SymptoMScreen Score
Time frame: Up to 2 Years
Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)
Time frame: Up to 2 Years
Percentage of Participants with Adverse Events
Time frame: Up to 2 Years
Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period
Time frame: Up to 2 years