EUCTR2020-004128-41-PL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 inclusive
- •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 Treatment
- •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 non
- •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
- •Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
- •Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate within 24 months prior to treatment allocation
- •Treatment with natalizumab within 12 months prior to randomization
- •Previous treatment with fingolimod
- •Treatment with teriflunomide within 24 weeks prior to treatment allocation (or within 4 weeks if patients have completed an accelerated washout procedure for teriflunomide (confirmation of drug plasma level of < 0.02mg/L required))
- •Treatment with any other S1P receptor modulator within 24 weeks prior to treatment allocation
- •Treatment with dimethyl fumarate within 4 weeks prior to treatment allocation
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