Ocrelizumab Pregnancy Registry

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OCRELIZUMAB
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  580

Study design details

• Main study objective:
  The main objective of the study is to assess and characterize frequency of maternal, fetal, and infant outcomes among women with MS exposed to ocrelizumab during the 6 months before the estimated date of conception or at any time during pregnancy.
• Outcomes:
  - Frequency of selected adverse pregnancy outcomes - Frequency of selected adverse fetal/neonatal/infant outcomes - Compare the maternal, fetal, and infant outcomes with unexposed comparator
• Data analysis plan:
  Descriptive statistics will be used to summarize the findings, specifically, overall frequency (prevalence, 95% CI) of selected adverse pregnancy outcomes will be calculated, as well as frequencies of specific outcomes.Prevalence and associated 95% CIs will also be calculated for selected adverse fetal, neonatal, and infant outcomes at birth and through at least the first year of life of infants from pregnancies in women with MS exposed to ocrelizumab.The comparison to ocrelizumab-exposed women to the internal unexposed comparator will be performed using risk ratios (95% CIs) unadjusted and adjusted to relevant covariates, if sufficient number of outcomes are available.