EINE OFFENE, EINARMIGE STUDIE ZUR UNTERSUCHUNG DER WIRKSAMKEIT UND SICHERHEIT VON OCRELIZUMAB BEI PATIENTEN MIT SCHUBFÖRMIG REMITTIERENDER MULTIPLER SKLEROSE (MS) IM FRÜHSTADIUM

Drug: Ocrelizumab

Gender: All
Maximum age: 55 Years
Minimum age: 18 Years

Inclusion Criteria:

- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria

- Have a length of disease duration, from first documented clinical attack consistent
with MS disease of less than or equal to (
- Within the last 12 months one or more clinically reported relapse(s) or one or more
signs of MRI activity

- EDSS of 0.0 to 3.5 inclusive, at screening

- An agreement to use an acceptable birth control method for women of childbearing
potential, during the treatment period and for at least 6 months or longer after the
last dose of study drug

Exclusion Criteria:

- Secondary progressive multiple sclerosis or history of primary progressive or
progressive relapsing MS

- Inability to complete an MRI

- Known presence of other neurological disorders

Exclusions Related to General Health:

- Pregnancy or lactation

- Participants intending to become pregnant during the study or within 6 months after
the last dose of the study drug

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

- History or currently active primary or secondary immunodeficiency

- Lack of peripheral venous access

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

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

- Congestive heart failure (New York Heart Association III or IV functional severity)

- Known active bacterial, viral, fungal, mycobacterial infection or other infection,
(excluding fungal infection of nail beds) or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or
oral antibiotics 2 weeks prior to screening

- History of malignancy, major opportunistic infections, alcohol or drug abuse,
recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

- Received any prior approved disease modifying treatment (DMT) with a label for MS, for
example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab,
fingolimod, teiflunomide and dimethylfumarate

- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the
baseline visit

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

- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic
therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine,
methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone
marrow transplantation)

- Treatment with investigational DMT

- Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to
screening

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment