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

Part of paid clinical trials in La Jolla, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04933552
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Siponimod — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2021
Status verified
May 2024
Primary completion
May 31, 2032
Completion
May 31, 2032

Study Design

Enrollment
867 participants (estimated)

Arms

  • Arm: Siponimod-Exposed
    Pregnant women with MS exposed to siponimod during pregnancy
  • Arm: Disease-Matched Comparison
    Pregnant women with MS not exposed to siponimod during pregnancy
  • Arm: Healthy Comparison
    Pregnant women who are neither diagnosed with MS nor with any other autoimmune disease, and not exposed to siponimod or any known teratogenic agent during pregnancy

Primary Outcome Measure

Prevalence of major structural defects [ Time Frame: Up to 10,5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteLa JollaCalifornia92093-0934-

Find similar trials in La Jolla, CA

By condition
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By research site
Novartis Investigative Site· La Jolla, CA

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