Observational Study Monitoring Pregnancy Safety in Women with Neuromyelitis Optica Spectrum Disorder Exposed to UPLIZNA

What this Trial Is About

Researchers are conducting an observational study to monitor women with Neuromyelitis Optica Spectrum Disorder NMOSD who were exposed to UPLIZNA during pregnancy. The purpose is to collect detailed information on pregnancy outcomes and related factors in this group. This study spans at least 10 years to gather long-term safety data about UPLIZNA exposure during pregnancy or within six months before conception. Female participants with NMOSD who have received UPLIZNA at any time during pregnancy or within six months before conception will be observed. There is no administration of study drug during the trial. The schedule of medical visits and treatment routines will be determined by each participants healthcare provider, allowing personalized care throughout the study. Participants will voluntarily report pregnancies and related data, which may include pregnancy outcomes and potential confounding factors. Researchers will monitor newborn health outcomes such as major and minor congenital malformations, preterm birth, low birth weight, stillbirths, developmental milestones, neurological and immune system abnormalities, and pregnancy loss over a minimum of 10 years. This extensive follow-up will help understand the safety profile of UPLIZNA exposure in pregnancy.

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