Monitoring the safety of UPLIZNA in pregnant women with NMOSD
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
This study is trying to see how safe the medication UPLIZNA is for pregnant women with Neuromyelitis Optica Spectrum Disorder (NMOSD) by tracking their pregnancies and outcomes over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Amgen Industry-sponsored |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05909761 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women of reproductive potential with a confirmed or suspected diagnosis of NMOSD who have been exposed to UPLIZNA during pregnancy.
Not a fit: Patients who are not pregnant or have not been exposed to UPLIZNA during pregnancy or within the preceding six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of UPLIZNA during pregnancy, potentially guiding treatment decisions for women with NMOSD.
How similar studies have performed: While there may be limited data on similar studies, the observational nature of this study is crucial for understanding the implications of UPLIZNA exposure during pregnancy, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.