Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pregnancy Exposure Registry
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, observational registry

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DIMETHYL FUMARATE

  PEGINTERFERON BETA-1A
• Medical condition to be studied:
  Exposure during pregnancy

  Multiple sclerosis

Population studied

• Short description of the study population:
  The study population included pregnant women diagnosed with multiple sclerosis (MS) who were exposed to a registry-specified Biogen MS product or who were unexposed to DMTs during the eligibility window for that product.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Other

  Pregnant women
• Special population of interest, other:
  Patients with multiple sclerosis
• Estimated number of subjects:
  1125

Study design details

• Main study objective:
  The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate and peginterferon beta-1a.
• Outcomes:
  Pregnancy loss: elective or therapeutic pregnancy terminations, spontaneous abortions (<22 weeks of gestation), fetal death/stillbirths (fetuses born dead at >=22 weeks of gestation), further classified as early fetal loss (fetal death occurring at >=22 weeks but <28 weeks of gestation) or late fetal loss. Live birth: premature or full-term birth (delivered <37 weeks or >=37 weeks respectively).
• Data analysis plan:
  All cases will be reviewed based on earliest exposure within the associated eligibility window to a Registry-specified Biogen MS product. If a patient is exposed to multiple Registry-specified Biogen MS products within the product’s eligibility window, the case will be reviewed based on the earliest exposure. The Coordinating Center and Biogen Safety and Benefit-Risk Management will carefully review each pregnancy outcome and the calculations of risks of negative pregnancy outcomes. The prevalence of birth defects and spontaneous abortions and 95% confidence intervals (CIs) for the Registry population will be calculated to assess the presence or absence of any excessive risk associated with exposure to a Registry-specified Biogen MS product. All analyses will be conducted on an overall basis, as well as stratified by earliest trimester exposure. Other negative pregnancy outcomes will be similarly examined as sample size in each cohort permits.