Multiple Sclerosis Clinical Trial
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 â‰¥ 10 to â‰¤ 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.
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
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
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There are 12 Locations for this study
Aurora Colorado, 80045, United States
Washington District of Columbia, 20010, United States
Boston Massachusetts, 02115, United States
Saint Louis Missouri, 63110, United States
Cleveland Ohio, 44106, United States
Roma Lazio, 00165, Italy
Roma Lazio, 00189, Italy
Catania Sicilia, 95123, Italy
Gda?sk , 80-95, Poland
Pozna? , 60-35, Poland
Warszawa , 02-09, Poland
Warszawa , 04-73, Poland
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