Study type

Study topic

Human medicinal product

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
Other

Non-interventional study design, other

Enhanced pharmacovigilance program
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

PONESIMOD

Anatomical Therapeutic Chemical (ATC) code

(L04AA50) ponesimod
ponesimod

Medical condition to be studied

Multiple sclerosis
Premature baby
Congenital anomaly
Abortion spontaneous
Abortion induced
Ectopic pregnancy
Anembryonic gestation
Population studied

Age groups

  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Adolescents (12 to < 18 years)
  • 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

This study aims to evaluate the potential risk of reproductive and embryofetal toxicity in pregnant women exposed to ponesimod.

Outcomes

Estimate the proportion of major congenital malformations (according to EUROCAT classification) associated with exposure to ponesimod, immediately before (up to 1 week prior to last menstrual period LMP) and during pregnancy in live births, and in the group of live births, still births and termination of pregnancy for fetal anomaly (TOPFA). Characterize the proportion of major congenital malformations by the MedDRA system organ classes (SOCs). Estimate the proportion of minor congenital malformations (according to EUROCAT classification standards) associated with exposure to ponesimod, immediately before (up to 1 week prior to LMP) and during pregnancy in live births, and in the group of live births, still births and TOPFA.

Data analysis plan

No formal statistical hypothesis testing is planned. All summaries and analyses will be of a descriptive nature. Descriptive statistics with corresponding 95% confidence intervals using Clopper-Pearson (exact) method will be the main statistical methodology, eg: • continuous variables, will be summarized using number of participants (n), mean, standard deviation, median, minimum, and maximum. • categorical variables will be summarized for each category with number of participants and percentages. • the number of missing values will be displayed for all variables