Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study
Novartis Pharmaceuticals
Summary
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.
Description
The prevalence of each outcome in women exposed to siponimod and their infants will be compared to those observed in two unexposed comparator groups: a disease-matched comparison group of women who have not used siponimod during pregnancy but have been diagnosed with MS (disease-matched unexposed comparison group), and a comparison group of healthy women who do not have diagnosis of MS, have not had exposure to a known human teratogen, and have not taken siponimod in pregnancy (healthy comparison group). Pregnant women exposed to siponimod who do not meet the prospective cohort criteria will a…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 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 1. Pregnant women 2. Diagnosed with MS, with the indication validated by medical records when possible 3. 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 4. Agree to the conditions and requirements of the study including the interview schedule, release of m…
Interventions
- OtherSiponimod
Prospective observational cohort study. There is no treatment allocation. Patients administered siponimod, that have started before inclusion of the patient into the study will be enrolled.
Location
- Novartis Investigative SiteLa Jolla, California