A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

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
• •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