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

Launched by AMGEN · Jun 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called UPLIZNA® in women who are pregnant or planning to become pregnant and have a condition called Neuromyelitis Optica Spectrum Disorder (NMOSD). The goal is to gather information about how UPLIZNA affects pregnancy and any outcomes related to it. Women who are eligible for this study are those who can become pregnant, have been diagnosed with NMOSD, and have received UPLIZNA either during their pregnancy or in the six months before becoming pregnant.

If you participate in this study, you'll be asked to report your pregnancy and share information about your health and any pregnancy-related details. The study lasts for at least 10 years, and you'll have regular check-ins with your healthcare provider, who will help guide your care and treatment. This trial is currently looking for participants, and your involvement can help improve understanding of how UPLIZNA affects pregnancy for women with NMOSD.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply