Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
⁃ Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:
⁃ Cohort 1: Siponimod-Exposed Cohort
• Pregnant women
• Diagnosed with MS, with the indication validated by medical records when possible
• Exposure to siponimod for the treatment of MS, for any number of days, at any dose, and at any time from the 4th day post the first day of LMP prior to conception up to and including the end of pregnancy
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and the Ages and Stages Questionnaire (ASQ) in live born children
⁃ Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
• Pregnant women
• Diagnosed with MS, with the indication validated by medical records when possible
• May or may not have taken another medication for MS in the current pregnancy
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and the ASQ in live born children
⁃ Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
• Pregnant women
• Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and the ASQ in live born children