Multiple Sclerosis
Conditions
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.
Interventions
DRUGOcrelizumab
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mean change from inclusion in parent study in EDSS score over the course of the treatment | Up to 2 years | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time | Up to 2 Years | — |
| Time to first protocol-defined event of disease activity | Up to 2 Years | — |
| Presence and evolution of leptomeningeal follicles as detected by MRI | 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 | — |
| 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 FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period | 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 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). |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom
Outcome results
None listed