An International Pregnancy Exposure registry of Women With Multiple Sclerosis (MS) exposed to Teriflunomide (OBS12751)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Voluntary, international, prospective, observational, exposure registration study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The study population included pregnant women with multiple sclerosis (MS) received treatment with teriflunomide identified from the multiple countries: Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom.; Inclusion criteria: ; - Is pregnant ; - Has MS and was exposed to teriflunomide during pregnancy as defined below: a/ inadvertently received any teriflunomide dose at any time during pregnancy (from the first day of the last menstrual period to end of pregnancy), regardless of the dose or duration of use, OR b/ received any teriflunomide dose prior to pregnancy start and had teriflunomide plasma concentration greater than or equal to 0.02 mg/L measured during pregnancy and available/retrievable for the confirmation of enrolment ; - Has provided written informed consent to participate in the registry, through her HCP ; - Authorizes the release of medical information to the National Coordinator for herself and her live born infant(s), as applicable ; - Agrees to provides contact information for herself, her HCP, and her infant's HCP, as applicable; ; Exclusion criteria ; - Does not receive health care in a country in which the registry is operational ; - Was participating in a clinical trial investigating teriflunomide at the time of pregnancy exposure
• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Other

  Pregnant women
• Special population of interest, other:
  Patients with multiple sclerosis
• Estimated number of subjects:
  196

Study design details

• Main study objective:
  This registry aims to monitor pregnancies among women with MS who were inadvertently exposed to teriflunomide during pregnancy to evaluate the risk of birth defects in their infants and fetuses. In addition, the registry will evaluate the potential impact of prenatal teriflunomide exposure on pregnancy and infant health, growth, and development.; The primary objective of this registry is:; -To compare the rate of birth defects (major congenital malformations diagnosed up to one year of age, fetal deaths occurring at 20 gestation weeks or later, and termination of pregnancy for fetal anomaly following prenatal diagnosis (TOPFA)) with the rate of the same birth defects reported by the European Surveillance of Congenital Anomies (EUROCAT), a population based birth defect surveillance system.
• Outcomes:
  major congenital malformations diagnosed up to one year of age, fetal deaths occurring at 20 gestation weeks or later, and termination of pregnancy for fetal anomaly following prenatal diagnosis (TOPFA), Pregnancy outcomes including live born infants, recognized spontaneous abortions occurring at less than 20 gestation weeks, fetal deaths occurring at 20 gestation weeks or later, induced abortions without reported evidence of birth defects, TOPFA, ectopic pregnancy, and molar pregnancy Pregnancy exposure to teriflunomide and the elimination procedure
• Data analysis plan:
  For the primary analysis, the rate of birth defects among infants and fetuses prenatally-exposed to teriflunomide and reported to the Registry is calculated by dividing the number of birth defects among live born infants (LB), fetal deaths (>20 weeks’ gestation) (FD), and TOPFA (at any gestational age) by the total number of LB, FD, and TOPFA with and without birth defects.