Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates
 effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will
 consist of an open-label treatment period of 192 weeks and follow-up period of at least 48
 weeks.

 The optional shorter infusion substudy will evaluate the safety of a shorter infusion of
 ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143
 study. Approximately 700 patients will be enrolled in the substudy, and will receive
 additional 600 mg ocrelizumab administered in a shorter time frame.
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 (</=) 3 years

 -  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