CTRI/2023/05/053033尚未招募3 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 - Operetta 2
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
入选标准
- •a)General Inclusion CriteriaPatients must meet the following criteria for study entry:1 Informed consent for study participation signed by the parents or a legal guardian,with patient assent obtained verbally and when possible,in writing,from all pediatric patients old enough to fully comprehend the assent document prior to any study-specific screening procedures, as per local requirements.2 Able to comply with the study protocol, in the investigators judgment Patients who are unable to complete exploratory assessments (e.g SDMT or questionnaires) due to physical disease limitations will not be excluded from the study.3 Age between greater than or equal to 10 to less than 18 years at randomization.4 Body weight greater than or equal to 25 kg. Note:Patients weighing greater than or equal to 25 kg to less than 50 kg will not be enrolled until the ocrelizumab dose is confirmed for patients less than 50 kg.5 Children and adolescents must have received all childhood vaccinations as per local and or national recommendations for childhood vaccination against infectious diseases.Patients negative for serological testing for varicella zoster will have the full course of the vaccine for chickenpox completed before study starts, except patients who have already received the full course of the vaccine for chickenpox,depending on local regulations.6 For female patients of childbearing potential:agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception,as defined below:Female patients must remain abstinent or use two methods of contraception, including at least one method with a failure rate of less than 1percentage per year,during the treatment period and for at least 24 weeks after the final dose of ocrelizumab or ocrelizumab placebo and for 2 months after the final dose of fingolimod or fingolimod placebo (see Section 5.1.5).Adherence to local requirement,if more stringent is required.7 A female is considered to be of childbearing potential if she is postmenarchal and is not permanently infertile due to surgery (i.e.removal of ovaries, fallopian tubes, and or uterus) or another cause as determined by the investigator (e.g.Müllerian agenesis).The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.8 Examples of contraceptive methods with a failure rate of less than 1percentage per year include the following:Established hormonal contraception:combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) or progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).9 Intrauterine devices: intrauterine device, intrauterine hormone releasing system, and copper intrauterine device A barrier method may be used as the second contraceptive method, such as the following:A male or female condom with or without spermicide A cap,diaphragm or sponge with spermicide.10 The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (ecalendar,ovulation,symptothermal,or postovulation methods) and withdrawal are not acceptable methods of contraception.If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local
排除标准
- •1 Pregnancy or lactation.2 Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS,including, but not limited to,ADEM,neuromyelitis optica or neuromyelitis optica spectrum disorders,and any neurological (other than MS),somatic or metabolic condition that could interfere with brain function or normal cognitive or neurological development.In case of an ADEM like appearance of the first MS relapse,a second relapse with clear MS like features is required.3 Patients that are aquaporin 4 (AQP4) positive and or myelin oligodendrocyte glycoprotein (MOG) antibody positive at screening 4 Clinical or laboratory findings at first presentation not typically for MS, such as signs of infection,signs of encephalopathy such as confusion,convulsion, reduced state of consciousness 5 Abnormal findings in the cerebrospinal fluid (CSF) at first MS presentation.Protein greater than 100 mg per dL.Pleocytosis greater than 50 cells per mm3.Presence of neutrophils or eosinophils above the normal reference range per local laboratory,or atypical cells. Note: CSF sampling is not mandated at screening and may be performed at investigator discretion to confirm diagnosis of pediatric RRMS.6 Atypical MRI findings:ADEM-like presentation of lesions;lesions in atypical location for MS;bilateral optic neuritis;extensive spinal cord lesions (greater than and equal to 3 spinal segments)7 Significant uncontrolled somatic diseases or any other significant condition that may preclude patient from participating in the study 8 Known active bacterial,viral,fungal,mycobacterial infection or other infection,excluding fungal infection of nail beds 9 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.10 History or known presence of recurrent or chronic infection (HIV,syphilis,tuberculosis) 11 Receipt of any type of vaccine (live or liveattenuated, non live) within 6 weeks prior to treatment allocation.The patients 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)12 History or laboratory (local laboratory test) evidence of clinically significant coagulation disorders (any coagulation disorder requiring medical treatment) 13 Peripheral venous access that precludes IV administration and venous blood sampling as required per study protocol 14 Inability to complete an MRI scan (due to weight, claustrophobia, hypersensitivity to gadolinium, cochlear implants,presence of foreign substances in the eye,or intracranial vascular clips) 15 Teeth braces interfering with MRI acquisition (see Section 4.6.5 for more information)16 History of cancer,including solid tumors,hematologic malignancies,and carcinoma in situ(except basal cell and squamous cell carcinoma of the skin that have been excised and cured)17 Currently active alcohol or drug abuse or history of alcohol or drug abuse. Exclusion Criteria Related to General Health Specific to Fingolimod Treatment:18 History of symptomatic bradycardia,recurrent syncope,significant QT prolongation (corrected QT interval [QTc] greater than 460 msec (pediatric female) or greater than 450 msec (pediatric male),patients having risk factors for QT prolongation such as hypokalemia or congenital QT prolongation,and uncontroll
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