Last updated 13 months ago
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
36 patients around the world
Available in United States, Mexico
Hoffmann-La Roche
1Research sites
36Patients around the world
This study is for people with
Multiple sclerosis
Pediatric multiple sclerosis
Requirements for the patient
To 18 Years
All Gender
Medical requirements
- Body weight >/= 25 kgChildren and adolescents must have received all childhood required vaccinationsFemale participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraceptionDiagnosis of relapsing-remitting multiple sclerosis (RRMS)Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusiveNeurologic stability for >/= 30 days prior to screening, and between screening and baselineParticipants 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 developmentPatients 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 agentsHistory 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 allocationHistory or laboratory evidence of coagulation disordersPeripheral venous access that precludes IV administration and venous blood samplingInability to complete a magnetic resonance imaging (MRI) scanHistory of cancer, including solid tumors, hematologic malignancies, and carcinoma in situHistory of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solutionPrevious treatment with B-cell-targeted therapiesPercentage of CD4 < 30%Absolute Neutrophil Count < 1.5x1000/microliterLymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range
Sites
Clinstile S.A de C.V.
Recruiting
SponsorHoffmann-La Roche
Conditions
Pediatric multiple sclerosis
Requirements
To 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04075266
