NL-OMON56373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
- 入组人数
- 3
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
- 2 至 17（—）
入选标准
- •Patients must meet the following criteria for study entry:
- •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
- •Able to comply with the study protocol, in the investigator's judgment
- •Patients who are unable to complete exploratory assessments (e.g., SDMT or
- •questionnaires) due to physical/disease limitations will not be excluded from
- •Age between >= 10 to <18 years at randomization
- •Body weight >= 25 kg
- •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 start, except
- •patients who have already received the full course of the vaccine for
- •chickenpox, depending on local regulations.
- •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 < 1% per year, 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. Adherence to local requirement, if more
- •stringent, is required.
- •A female is considered to be of childbearing potential if she is postmenarcheal
- •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.
- •Examples of contraceptive methods with a failure rate of < 1% per year include
- •the following:
- •o 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)
- •o 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
- •o A male or female condom with or without spermicide
- •o A cap, diaphragm, or sponge with spermicide
- •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 (e.g., calendar, 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 Informed Consent Form.
- •Inclusion Criteria Related to Pediatric Multiple Scl
排除标准
- •While participating in this study, patients are not allowed to take part in
- •other investigational research projects involving administration of any drug or
- •substance or involving any procedure that would place patients at risk or could
- •jeopardize this study results.
- •Exclusions Related to General Health
- •Patients who meet any of the following criteria related to general health will
- •be excluded from study entry:
- •Pregnancy or lactation
- •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 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.
- •Patients that are aquaporin-4 positive and/or myelin oligodendrocyte
- •glycoprotein antibody positive at screening
- •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.
- •Abnormal findings in the cerebrospinal fluid (CSF) at first MS presentation.
- •Protein * 100 mg/dL. Pleocytosis * 50 cells/mm3. Presence of neutrophils or
- •eosinophils above the normal reference range per local laboratory, or atypical
- •Note: CSF sampling is not mandated at screening and may be performed at
- •investigator discretion to confirm diagnosis of pediatric RRMS.
- •Atypical MRI findings: ADEM like presentation of lesions; lesions in
- •atypical location for MS; bilateral optic neuritis; extensive spinal cord
- •lesions (* 3 spinal segments)
- •Significant uncontrolled somatic diseases or any other significant condition
- •that may preclude patient from participating in the study
- •Known active bacterial, viral, fungal, mycobacterial infection, or other
- •infection, excluding fungal infection of nail beds
- •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 (e.g., HIV,
- •syphilis, tuberculosis)
- •Receipt of any type of vaccine (e.g. live, live-attenuated vaccine, non-live)
- •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, as per local guidelines).
- •History or laboratory (local laboratory test) evidence of clinically
- •significant coagulation disorders (e.g., any coagulation disorder requiring
- •medical treatment).
- •Peripheral venous access that precludes IV administration and venous blood
- •sampling as required per study protocol
- •Inability to complete an MRI scan (e.g., due to weight, claustrophobia,
- •hypersensitivity to gadolinium, cochlear implants, presence of foreign
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