The UPLIZNA Pregnancy Registry

What is the UPLIZNA Pregnancy Registry?

The UPLIZNA Pregnancy Registry is a global registry for women who are or have been pregnant while taking UPLIZNA^® (inebilizumab). This is defined as taking inebilizumab within the 6 months before getting pregnant or at any time during pregnancy. The purpose of this pregnancy registry is to learn more about the health of pregnant women who have received inebilizumab and the health of their babies.

Participants will be followed throughout their pregnancy, and information on the health of their babies will also be collected during their baby’s first year of life.

Because of this registry, pregnant women who are exposed to inebilizumab in the future may have more information about how their pregnancies and babies may be affected.

Can I take part in this registry?

You may be able to take part in this registry if you:

• have diagnosed or suspected NMOSD
  and
• have taken inebilizumab within the 6 months before getting pregnant or at any time during your pregnancy.

What will I have to do?

To take part in this pregnancy registry, a study doctor or a member of the study team from the coordinating center will first ask you to give verbal or written informed consent, depending on local regulations. This means that you will receive information about the registry and what participation will involve, have a chance to ask any questions, and decide if you want to take part. If you are a parent or legally authorized representative of a child with NMOSD who is younger than 18 years of age, is or has been pregnant, and has received inebilizumab, you will be asked to provide informed consent on your child’s behalf.

If you decide to participate and you have (or on behalf of your child) given informed consent, the study doctor or a member of the study team designated by the study doctor will contact you. You and/or your healthcare provider will need to complete questionnaires about you and your pregnancy. Initial, follow-up, and final data will be collected for up to 8 weeks after the end of your pregnancy.

If consent is given, data will be collected when your baby is about 3, 6, and 12 months old, to find out about breastfeeding (if applicable) and your baby’s health.

If you are not pregnant now but have previously been pregnant while taking inebilizumab, and you decide to participate and provide informed consent, a study doctor or member of the study team will call you once to ask a set of questions and collect information about you, your pregnancy, your health, breastfeeding (if applicable), and your baby’s health.

After you enroll in the registry, you can choose to stop taking part in the registry at any time. This will not affect the care you receive.

If you participate in the registry, you will not:

• have any medical visits specifically for this registry
• have any medical tests for the registry
• receive any medications for the registry.

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