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 Trial

简要总结

主要结局

次要结局

• 1. Related to disability progression: Time to onset of Confirmed disability progression (CDP) sustained for at least 24 weeks and for at least 48 weeks
• 2. Related to disability progression: Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of treatment
• 3. Related to disability progression: Proportion of patients who have improved, stable or worsened disability compared with baseline (inclusion in the study) measured by expanded disability status scale (EDSS)
• 4. Related to disability progression: Mean change from inclusion in the parent study in EDSS score over the course of treatment
• 5. Related to disability progression: 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 over the duration of treatment
• 6. Other clinical measures and composite endpoints: Time to first protocol-defined event of disease activity
• 7. Other clinical measures and composite endpoints: Time to first relapse
• 8. Other clinical measures and composite endpoints: Annualized relapse rate
• 9. Other clinical measures and composite endpoints: Proportion of patient relapse free, yearly and over the course of treatment
• 10. Other clinical measures and composite endpoints: Proportion of patients with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment
• 11. Other clinical measures and composite endpoints: Proportion of patients with no evidence of progression, measured by EDSS, 9HPT and T25FW (if assessments are available)
• 12. Other clinical measures and composite endpoints: Proportion of patients with no evidence of progression sustained for at least 24 weeks and no active disease (if assessments are available)
• 13. Other clinical measures and composite endpoints: Change from baseline (parent trial) in cognitive performance as measured by the Symbol digit modalities test (SDMT)
• 14. Related to MRI: Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
• 15. Related to MRI: Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
• 16. Related to MRI: Change in total T1 hypointense lesion volume over time
• 17. Related to MRI: Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time (pertinent to CASTING/MA30005 patients only)
• 18. Related to MRI: Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period
• 19. Related to MRI: Change in brain volume (including white and grey matter fractions) as detected by brain MRI over time
• 20. Related to MRI: Presence and evolution of leptomeningeal follicles (pertinent to ENSEMBLE/MA30143 patients with identified FLAIR late enhancing lesions and CASTING /MA30005 patients)
• 21. Other measures related to MS disease:Time to treatment discontinuation/switch
• 22. Patient reported outcomes (PROs):Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
• 23. Patient reported outcomes (PROs):SymptoMScreen score
• 24. Patient reported outcomes (PROs):Quality of life (Multiple Sclerosis Impact Scale [MSIS]-29)
• 25. Rate and nature of adverse events
• 26. Changes in vital signs, neurological examinations, clinical laboratory results, locally reviewed MRI for safety (non-MS CNS pathology) and concomitant medications