NCT04933552

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent (Siponimod): An OTIS Observational Pregnancy Surveillance Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 867 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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 also be followed as part of an exposure series. All participants will be recruited via voluntary participant registration following informed consent by the pregnant woman for her participation. Participants may withdraw from the study at any time.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Siponimod	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.

Timeline

• Start date: 2021-12-15
• Primary completion: 2032-05-31
• Completion: 2032-05-31
• First posted: 2021-06-21
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States