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

Recruiting Observational Study
Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Female
Study type
Observational
Participants needed
867 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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. Exposur…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Diana Johnson

1-877-311-8972

mothertobaby@health.ucsd.edu

CONTACT