RecruitingNCT04933552

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

Sponsor

Novartis Pharmaceuticals

Enrollment

867 participants

Start Date

Dec 15, 2021

Study Type

OBSERVATIONAL

Conditions

Multiple Sclerosis

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This registry study tracks pregnancy outcomes for women with multiple sclerosis (MS) who were exposed to a medication called siponimod (brand name: Mayzent) during or around their pregnancy, to understand if it is safe. **You may be eligible if...** - You are pregnant - You have been diagnosed with multiple sclerosis (MS) - You took siponimod at any point from around conception through the end of your pregnancy - You are willing to attend interviews and allow review of your medical records **You may NOT be eligible if...** - You have not been exposed to siponimod during your pregnancy - You are not willing to allow follow-up for your baby after birth - You do not have a diagnosis of MS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Novartis Investigative Site

La Jolla, California, United States

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NCT04933552

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