Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15+
SponsorAmgen
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- UPLIZNA
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov