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

Multiple sclerosis is a chronic disease that requires lifelong treatment in
order to reduce frequency of relapse and accumulation of disability. Once a
patient is diagnosed with definite MS, accepted treatment guidelines propose
that he/she be offered lifelong treatment, as there is no evidence to suggest
that MS spontaneously remits. Results of long-term, follow-up studies suggest
that exposure to DMT for more than 2 years improves outcomes by delaying the
time to disability progression. Moreover, a majority of MS patients treated
with a DMT, who discontinued therapy, had a return of their baseline disease
activity after approximately 2 years.

Previous phase III randomized clinical trials with ocrelizumab have
demonstrated a favourable benefit-risk ratio of ocrelizumab in RMS and PPMS
patients. The ongoing/planned phase IIIb/IV trials (parent trials) will further
evaluate the effectiveness and safety of ocrelizumab in MS patients. Based on
the favourable profile of ocrelizumab, it is justified to offer ocrelizumab to
patients who may benefit from the continuation of the therapy with ocrelizumab
in order to reduce the frequency of relapses and delay disability progression
after their trial has stopped. Furthermore, Roche had committed to provide
treatment for above mentioned patients in the parent trial.

This study has been transitioned to CTIS with ID 2023-506543-41-00 check the CTIS register for the current data.

This Extension study will evaluate the effectiveness and safety of ocrelizumab
in MS patients who were previously enrolled in a Roche sponsored ocrelizumab
phase IIIb/IV parent trial.

This is a single arm, open label, multicenter Extension study in patients on
ocrelizumab therapy who are eligible for roll over based on the investigator
decision in the Roche Parent trial. Patients will receive treatment with
ocrelizumab as single 600 mg infusions in 500 mL 0.9% sodium chloride every 24
weeks up to Week 72 of this study. The study will consist of the following
periods:

-Screening period: The screening visit should be scheduled up to two weeks
prior to the first infusion of ocrelizumab. This period of time should not be
exceded.
-Treatment period: The first visit of the Treatment period (first infusion of
ocrelizumab) should be 24 weeks (±14 days) after the last infusion of
ocrelizumab in the parent trial. Ocrelizumab will be administered every 24
weeks up to Week 72 of this study and the last visit in the treatment period
will be conducted 24 weeks after the last dose of ocrelizumab.
-A follow-up period of at least 48 weeks.

Patients enrolled in this LIBERTO study will receive the first infusion of
ocrelizumab 24 weeks (±14 days) after the last infusion of ocrelizumab in the
parent trial. Ocrelizumab will be administered every 24 weeks uo to Week 72 of
this study and the last visit in the treatment period will be conducted 24
weeks after the last dose of ocrelizumab.

See section E9 of this ABR form; section 5 of the protocol and Patient
Information Sheet section 5 and Appendix D.