CTIS2023-507313-94-00进行中（未招募）1 期
An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis - WA39085
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •1.Body weight >= 25 kg Note: enrollment of patients with a body weight >= 40 kg is closed, 2.Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases, 3.For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 24 weeks after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required, 4.Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric multiple sclerosis (MS), Version 2012, and McDonald criteria 2017, 5.Expanded disability status scale (EDSS) at screening: 0-5.5, inclusive, 6.Patients who have had at least 6 continuous months of disease-modifying therapy (DMT) (e.g., any interferon [IFN] or glatiramer acetate [GA]) 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 gadolinium (Gd)-enhancing lesion(s) on a T1-weighted brain magnetic resonance imaging (MRI)
排除标准
- •1.Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis (ADEM), neuromyelitis optica or neuromyelitis optica spectrum disorders; and any neurologic (other than MS), 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, 2.Atypical MRI findings: ADEM-like presentation of lesions; lesions in atypical location for MS; bilateral soptic neuritis; extensive spinal cord lesions (>= 3 spinal segments), 3.Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds, 4.Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation. The patient's vaccination record and a need for immunization should be carefully reviewed (scheduled vaccinations should be completed at least 6 weeks prior to receiving ocrelizumab, according to local guidelines), 5.History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies (mAbs) or known hypersensitivity to any component of ocrelizumab solution, 6.Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]) or hepatitis C antibody (HepCAb)
研究者
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