A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and
 pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18
 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve
 to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent
 Phase III study in children and adolescents.
Inclusion Criteria:

 -  Body weight >/= 25 kg

 -  Children and adolescents must have received all childhood required vaccinations

 -  Female participants of childbearing potential must agree to either remain completely
 abstinent or to use reliable means of contraception

 -  Diagnosis of relapsing-remitting multiple sclerosis (RRMS)

 -  Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive

 -  Neurologic stability for >/= 30 days prior to screening, and between screening and
 baseline

 -  Participants naive to prior disease-modifying therapy (DMT)

 -  Participants who have had at least 6 contiguous months of DMT within the past 1 year
 must have evidence of disease activity occurring after the full 6-month course of
 treatment, that is, at least one relapse or >/= 1 Gd-enhancing lesion(s) on a
 T1-weighted brain MRI

 Exclusion Criteria:

 -  Known presence or suspicion of other neurologic disorders that may mimic MS,
 including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis
 optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or
 metabolic condition that could interfere with brain function or normal cognitive or
 neurological development

 -  Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG)
 antibody positive are not eligible to participate in the study.

 -  In case of an ADEM-like appearance of the first MS attack, a second attack with clear
 MS-like features is required.

 -  Infection requiring hospitalization or treatment with IV anti-infective agents

 -  History or known presence of recurrent or chronic infection (e.g., HIV, syphilis,
 tuberculosis)

 -  Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment
 allocation

 -  History or laboratory evidence of coagulation disorders

 -  Peripheral venous access that precludes IV administration and venous blood sampling

 -  Inability to complete a magnetic resonance imaging (MRI) scan

 -  History of cancer, including solid tumors, hematologic malignancies, and carcinoma in
 situ

 -  History of a severe allergic or anaphylactic reaction to humanized or murine
 monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab
 solution

 -  Previous treatment with B-cell-targeted therapies

 -  Percentage of CD4 < 30%

 -  Absolute Neutrophil Count < 1.5x1000/microliter

 -  Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific
 reference range