The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (Gilenya Pregnancy Registry)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pregnancy exposure registry

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Sentinel sites, Pregnancy Exposure Registry

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FINGOLIMOD HYDROCHLORIDE
• Medical condition to be studied:
  Pregnancy

  Multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The purpose of the Registry is to continuously monitor, evaluate and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period) and during pregnancy in routine clinical practice.
• Outcomes:
  Major and minor congenital malformations, other adverse maternal and fetal outcomes, physical developmental delays in offspring, adverse immune system effects in offspring.
• Data analysis plan:
  Descriptive statistics will be used to summarize the findings, Specifically, overall frequency (proportions, 95% confidence interval) of major malformations will be calculated as well as frequencies of specific outcomes, e.g. heart defect. ; The same will be calculated for minor congenital malformations, spontaneous abortions, stillbirths, elective terminations, adverse effects on immune system development, and any other adverse pregnancy outcomes. ; All primary analyses will be restricted to prospectively identified cases with outcome information. ; The findings in the pregnancy exposure registry will be compared to external comparison groups. External comparison groups will include the European Registration of Congenital Anomalies and Twins (EUROCAT) and the Metropolitan Atlanta Congenital Defects Program (MACDP).