Monitoring the safety of UPLIZNA in pregnant women with NMOSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to monitor female participants diagnosed with Neuromyelitis Optica Spectrum Disorder (NMOSD) who have been exposed to UPLIZNA during pregnancy or within six months prior to conception. Participants will voluntarily report their pregnancies, and the study will collect data on pregnancy outcomes, potential confounding factors, and other relevant information over a minimum duration of 10 years. The schedule of office visits and treatment regimens will be determined by the participants' healthcare providers.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Denver
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.