The ZEPOSIA MS Pregnancy Registry

Why is the registry important?

The registry will help us learn more about the safety of using ZEPOSIA® (ozanimod) and other multiple sclerosis medications during pregnancy.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States or Canada
  • A pregnant woman diagnosed with multiple sclerosis who has:
    • Not taken any multiple sclerosis medications during pregnancy
    • Taken ZEPOSIA® (ozanimod) during pregnancy or within 3 months prior to pregnancy
    • Taken other multiple sclerosis medications during pregnancy or just prior to pregnancy

*Please note: If your patient has taken certain multiple sclerosis medications (e.g., Gilenya®, Mayzent®, Ponvory™, Novantrone®, Mavenclad®) prior to or during pregnancy patients may not be eligible to participate. The registry staff can help determine your eligibility if you have taken these medications.

What is ZEPOSIA® (ozanimod)?

ZEPOSIA® (ozanimod) is a prescription medicine made by Celgene Corporation, a Bristol-Myers Squibb Company, that is used to treat relapsing forms of multiple sclerosis in adults.

Specifically, it is for the treatment of:

  • Clinically isolated syndrome
  • Relapsing-remitting disease
  • Active secondary progressive disease

How do I participate?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Contact Request Form here and a registry staff member will contact them

Email the registry team with their contact information at:

Call the registry team toll-free at
1-877-301-9314
(hours of operation 8.30am – 5.00 pm EST)

Why is this study needed?

Multiple sclerosis prevalence is highest during women’s childbearing years.1,2 Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of using multiple sclerosis medications during pregnancy on pregnancy and infant outcomes.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctor’s visits or additional testing
  • No changes to patients’ medications or care

Their doctors will receive compensation for providing data to the registry.

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Multiple sclerosis history
  • Baseline and ongoing pregnancy information, including pregnancy data and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant growth and development information

Healthcare providers will be compensated each time they submit data to the registry.

Eligible patients will be asked to provide basic demographic information (e.g. race, ethnicity, education), height, and weight to the registry at enrollment.

Thank you for your support in recruiting potential participants.

References

1. MacDonald SC, McElrath TF, Hernández-Díaz S. Pregnancy outcomes in women with multiple sclerosis. Am J Epidemiol. 2018;188(1):57-66.
2. Wallin MT, Culpepper WJ, Campbell JD, et al. The prevalence of MS in the United States: a population-based estimate using health claims data. Neurology. 2019;92:e1029-40.