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An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis


Brief Summary:

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety
study in participants with progressive multiple sclerosis (PMS).


Inclusion Criteria:

– Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS
or Lublin et al. 2014 criteria for PMS)

– EDSS (Expanded Disability Status Scale) 5.0

– Have a documented evidence of disability progression independent of relapse at any
point over the 2 years prior to the screening visit. In case relapse(s) have occurred
in the last 2 years, disability progression will have to be considered as independent
of relapse activity as per treating physician’s judgment

– Fulfill at least one of the 21 criteria assessing the evidence of disability
progression independent of relapse activity in the last 2 years using the pre-baseline
disability progression rating system checklist

– Have experience of having used a smartphone and connecting a smartphone to Wi-Fi
network providers

– For women of childbearing potential: agreement to remain abstinent or use acceptable
contraceptive methods during the treatment period and for at least 6 months, or longer
if the local label is more stringent after the last dose of study drug

Exclusion Criteria:

– Relapsing-remitting multiple sclerosis (RRMS) at screening

– Inability to complete an MRI

– Gadolinium (Gd) intolerance

– Known presence of other neurological disorders

Exclusions Related to General Health:

– Positive screening tests for hepatitis B

– Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at

– Lactation

– Any concomitant disease that may require chronic treatment of systemic corticosteroids
or immunosuppressants during the course of the study

– History or currently active primary or secondary immunodeficiency

– Lack of peripheral venous access

– Significant or uncontrolled somatic disease or any other significant disease that may
preclude participant from participating in the study.

– Active infections must be treated and resolved before possible inclusion in the study.

– Participants in a severely immunocompromised state until the condition resolves

– Participants with known active malignancies or being actively monitored for recurrence
of malignancy

– Participants who have or have had confirmed progressive multifocal leukoencephalopathy

Exclusions Related to Medications:

– Hypersensitivity to ocrelizumab or to any of its excipients

– Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab,
atacicept, tabalumab, belimumab, ofatumumab, or obinutizumab)

– Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body
irradiation, or bone marrow transplantation

– Previous treatment with natalizumab where PML has not been excluded according to
specific algorithm

– Contraindications to or intolerance of oral or intravenous (IV) corticosteroids,
including methylprednisolone administered IV, according to the country label

– Systemic corticosteroid therapy within 4 weeks prior to screening

– All vaccines should be given at least 6 weeks before the first infusion of
ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and
safety follow-up period until B cells are peripherally repleted

– Previous treatment with daclizumab or figolimod in the last 8 weeks

– Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS
treatment unless on stable dose for ≥30 days prior to screening

– Previous treatment with natalizumab in the last 12 weeks

– Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or
methotrexate in the last 12 weeks

– Treatment with any investigational agent within 24 weeks of screening (Visit 1) or
five half-lives of the investigational drug (whichever is longer) or treatment with
any experimental procedures for MS

– Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks

– Participants previously treated with teriflunomide within the last two years, unless
measured plasma concentrations are less than 0.02 mg/l. If above or not known, an
accelerated elimination procedure should be implemented before screening visit

Exclusions for Participants in the Optical Coherence Tomography (OCT) Assessments:

– Participants with clinically relevant ocular pathologies, potentially interfering with
clinical and instrumental evaluations

Exclusions for Participants Participating in the Measurement of Motor Evoked Potentials:

– History of seizures

– Prior craniotomy or skull fracture

– Movable metallic implant in the head

– Implanted stimulators (e.g. cochlear implant or cardiac pacemaker, deep brain

– Known history of high intracranial pressure


  • MS Center of California, Newport Beach, California, United States, 92663
  • SC3 Research Group, Inc, Pasadena, California, United States, 91105
  • University of California San Francisco, San Francisco, California, United States, 94117
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