EUCTR2020-004128-41-GR进行中（未招募）1 期
A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 171
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria
- •Able to comply with the study protocol, in the investigator's judgment
- •Age between >10 to <18 years at randomization
- •Body weight >=25 kilograms
- •Children and adolescents must have received all childhood
- •vaccinations as per local and/or national recommendations for childhood
- •vaccination against infectious diseases
- •Female patients of childbearing potential must agree to remain
- •abstinent (refrain from heterosexual intercourse) or use contraception
- •during the treatment period and for at least 24 weeks after the final
- •dose of ocrelizumab/ocrelizumab placebo and for 2 months after the
- •final dose of fingolimod/fingolimod placebo
- •Inclusion Criteria Related to Pediatric Multiple Sclerosis
- •Diagnosis of relapsing-remitting multiple sclerosis (RRMS) in
- •accordance with the international pediatric multiple sclerosis study
- •group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald
- •criteria 2017 (or the most current revision of the IPMSSG criteria or
- •McDonald criteria at the time of study start)
- •Confirmation of the diagnosis of Pediatric RRMS by the Independent
- •Pediatric MS Review Committee prior to randomization
- •Expanded disability status scale (EDSS) at screening: 0-5.5, both
- •At least one relapse during the year prior to screening or two relapses
- •in the previous two years prior to screening or evidence of at least one
- •Gd enhancing lesion on MRI within 6 months prior to randomization
- •(including screening MRI)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 171
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusions Related to General Health
- •Pregnancy or lactation
- •Known presence or suspicion of other neurologic disorders that may
- •Aquaporin-4 positive and/or myelin oligodendrocyte glycoprotein
- •antibody positive at screening
- •Clinical or laboratory findings at first presentation not typically for MS
- •Abnormal findings in the cerebrospinal fluid at first presentation
- •Atypical magnetic resonance imaging (MRI) findings
- •Significant uncontrolled somatic diseases or any other significant
- •Known active bacterial, viral, fungal, mycobacterial infection, or other
- •Infection requiring hospitalization or treatment with IV anti-infective
- •agents within 4 weeks prior to Day 1 visit or oral anti-infective agents
- •within 2 weeks prior to Day 1 visit
- •History or known presence of recurrent or chronic infection
- •Receipt of any type of vaccine (e.g., live or live-attenuated vaccine,
- •non-live) within 6 weeks prior to treatment allocation
- •History or laboratory evidence of clinically significant coagulation
- •Peripheral venous access that precludes IV administration and venous
- •blood sampling
- •Inability to complete MRI scan
- •Teeth braces interfering with MRI acquisition
- •History of cancer
- •Currently active or history of alcohol or drug abuse
- •Exclusion Criteria Related to General Health Specific to Fingolimod
- •History of symptomatic bradycardia, recurrent syncope, significant QT
- •prolongation.
- •Patients who in the previous 6 months had myocardial infarction,
- •unstable angina pectoris, stroke/transient ischemic attack,
- •decompensated heart failure, or New York Heart Association Class III/IV
- •heart failure
- •Patients with severe cardiac arrhythmias
- •Patients with second-degree Mobitz type II atrioventricular (AV) block
- •or third-degree AV block, sick-sinus syndrome or sinoatrial heart block
- •Patients with a baseline QTc interval >=500 milliseconds
- •Presence of macular edema
- •Presence of any pulmonary conditions, as determined by the
- •investigator
- •History of any type of epileptic seizure(s) as well as psychogenic
- •nonepileptic seizure(s) during the past 12 months before screening
- •Patients with chronic liver or biliary disease, acute or chronic
- •pancreatitis
- •Exclusion Criteria Related to Medications
- •History of a severe allergic or anaphylactic reaction to humanized or
- •murine MAbs or known hypersensitivity to any component of
- •ocrelizumab solution
- •Contraindications to or intolerance of oral or IV corticosteroids,
- •antihistamines, or antipyretics
- •Treatment with any investigational agent within 24 weeks of screening
- •or 5 half-lives
- •Previous treatment with B-cell-targeted therapies
- 另有 15 项未显示
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