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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will consist of participants who have been exposed to UPLIZNA during pregnancy and have signed an informed consent form (ICF).
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
UPLIZNA
DrugEnrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of newborns with Major Congenital Malformations (MCMs)
Time frame
Minimum of 10 years2
Number of newborns with Preterm birth
Time frame
Minimum of 10 years3
Number of newborns with low birth weight
Time frame
Minimum of 10 years4
Number of stillbirths
Time frame
Minimum of 10 yearsSecondary outcomes
1
Number of newborns with Minor Congenital Malformations
Time frame
Minimum of 10 years2
Number of infants with developmental milestone abnormalities
Time frame
Minimum of 10 years3
Number of infants with neurologic abnormalities
Time frame
Minimum of 10 years4
Number of infants with immune system development abnormalities
Time frame
Minimum of 10 years Source ClinicalTrials.gov