Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
About the study
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
EXCLUSION CRITERIA
Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Neuromyelitis Optica Spectrum Disorder,Pregnancy Related
Participants Needed
60
Est. Completion Date
Aug 31, 2032
Treatment Type
OBSERVATIONAL
Sponsor
Amgen
ClinicalTrials.gov NCT Identifier
NCT05909761
Study Number
VIB0551.P4.S4
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