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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- 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