A Phase III Multicenter Randomized Double-Blind Double-Dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple sclerosis (Operetta 2)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Rrms
  • Age: Between 10 - 18 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Able to provide written informed consent form
    2. Able to comply with the study protocol
    3. Body weight =25 kg
    4. Children and adolescents must have received all childhood vaccinations as per local and/or national recommendations for childhood vaccination against infectious diseases
    5. For female patients of childbearing potential will remain abstinent (refrain from heterosexual intercourse) or use contraception
    6. Diagnosis of Relapsing-Remitting Multiple sclerosis (RRMS)
    7. Expanded Disability Status Scale (EDSS) at screening: 0-5.5, both inclusive
    8. Neurologic stability for =30 days prior to screening, and between screening and Day 1
    9. At least one relapse during the year prior to screening or two relapses in the previous two years prior to screening

You may not be eligible for this study if the following are true:

    1. Are not allowed to take part in other investigational research projects involving administration of any drug or substance
    2. Pregnancy or lactation
    3. Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS
    4. Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds
    5. Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to Day 1 visit
    6. History or known presence of recurrent or chronic infection
    7. Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation.
    8. History or laboratory (local laboratory test) evidence of clinically significant coagulation disorders
    9. Peripheral venous access that precludes IV administration and venous blood sampling as required per study protocol
    10. Inability to complete an MRI scan
    11. Teeth braces interfering with MRI acquisition
    12. History of cancer
    13. Currently active alcohol or drug abuse or history of alcohol or drug abuse



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