Observational Safety Study of UPLIZNA® During Pregnancy for NMOSD

This is an observational study for women with Neuromyelitis Optica Spectrum Disorder (NMOSD), a rare, lifelong autoimmune disease of the central nervous system, who have been exposed to UPLIZNA® during pregnancy or up to six months before conception. The study aims to understand the safety of UPLIZNA® exposure during pregnancy by tracking the number of newborns with major birth defects, preterm birth, and low birth weight. You can join if you are a woman of reproductive potential with NMOSD who meets the exposure criteria. This study is currently collecting information, but its recruitment status is unclear. No study drug will be given; your healthcare provider will manage your treatment and appointments.

Study design
This is an observational study planning to enroll 60 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups.
What's involved
This study involves voluntary reporting of pregnancies. Your healthcare provider will determine your office visits and treatment regimens.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a minimum of 10 years to collect information on newborn outcomes.

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NCT05909761

Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

Recruiting
Not specifiedAges 15+Observational
Amgen
~60 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:UPLIZNA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of newborns with Major Congenital Malformations (MCMs)
Measured over Minimum of 10 years
+3 more outcomes measured
Neuromyelitis Optica Spectrum Disorder
Pregnancy Related
1 sites across 1 states
Colorado1
  • MD · STUDY_DIRECTOR · Amgen

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Eligibility criteria

Inclusion

Provide informed consent
Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception
  • Number of newborns with Major Congenital Malformations (MCMs)Minimum of 10 years
  • Number of newborns with Preterm birthMinimum of 10 years
  • Number of newborns with low birth weightMinimum of 10 years
  • Number of stillbirthsMinimum of 10 years