Clinical Trial Details
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NCT02637856 : A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
PhasePhase 3
AgesMin: 18 Years Max: 55 Years
Inclusion Criteria:

- Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised
2010 McDonald criteria

- Disease duration from first symptom of less than or equal to (
- Treated with an adequate course of treatment with no more than three prior DMT
regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the
most recent adequately used DMT was due to suboptimal response

- Suboptimal response while the participant was on his/her last adequately used DMT for
>/=6 months (defined by having one of the following qualifying events despite being
on a stable dose of the same DMT for at least 6 months: one or more clinically
reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or
enlarging T2 lesions on MRI); these qualifying events must have occurred while on the
last adequately used DMT. In participants receiving stable doses of the same approved
DMT for more than a year, the event must have occurred within the last 12 months of
treatment with this DMT from the date of screening

Exclusion Criteria:

- History of primary progressive multiple sclerosis (PPMS), progressive relapsing
multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)

- Contraindications for MRI

- Known presence of other neurological disorders that may mimic multiple sclerosis

- Pregnancy or lactation

- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study

- History of 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

- Active infection, or history of or known presence of recurrent or chronic infection
such as human immunodeficiency virus (HIV), syphilis, or tuberculosis

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or IV corticosteroids

- Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in
participants whose lymphocyte count is below the lower limit of normal (LLN)

- Treatment with alemtuzumab (Lemtrada®)

- Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate
mofetil, cyclosporine, or methotrexate

- Previous treatment with natalizumab within 12 months prior to screening unless
failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants
previously treated with natalizumab will be eligible for this study only if duration
of treatment with natalizumab was less than (<) 1 year and natalizumab was not used
in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status
(positive or negative) and titer (both assessed within the year of screening) must be
documented prior to enrollment

- Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to

- Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept,
belimumab, or ofatumumab)

- Treatment with a drug that is experimental (Exception: treatment with an experimental
drug that was subsequently approved in the participant's country is allowed)
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