The ENSPRYNG Pregnancy Registry

What is the ENSPRYNG Pregnancy Registry?

The ENSPRYNG Pregnancy Registry is a global registry for women who are or have been pregnant while taking ENSPRYNG^® (satralizumab). This is defined as taking satralizumab 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 satralizumab 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 satralizumab in the future may have more information about how their pregnancies and babies may or may not be affected.

Can I take part in this registry?

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

• are or have been pregnant
  and
• have taken satralizumab 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 satralizumab, you will be asked to provide informed consent on the child’s behalf.

If you decide to participate and you have (or on behalf of your child) given informed consent, a study doctor or member of the study team will:

• ask a set of questions to collect some information about you and your pregnancy (or your child and their pregnancy) via phone
• call once each trimester to ask if there have been any changes in your (or your child’s) pregnancy, condition, or general health; or any changes to the medications you (or your child) are taking; or to your (or your child’s) contact information
• call about 4 weeks after you (or your child) have given birth, and when the baby is about 3, 6, and 12 months old, to ask questions about breastfeeding (if applicable) and the baby’s health.

If you have given birth and 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 the birth of the baby, the father or legally authorized representative of the baby will also need to provide consent to collect health information about your baby.

After you enroll in the registry, the study doctor or a member of the study team designated by the study doctor will contact you. You can choose to stop taking part in the registry at any time. This will not affect the care you receive.

Why and when will my healthcare providers be contacted?

With your permission, a study doctor or member of the study team will contact your healthcare provider. This can be the healthcare provider caring for you during your pregnancy or treating your NMOSD (if different than your regular obstetrician), and/or your neurologist. After you give birth, your baby’s healthcare provider will also be contacted. The study doctor or member of the study team will collect information about your NMOSD and general health, your pregnancy, breastfeeding (if applicable), and your baby’s health. Following your enrollment, they will:

• contact your healthcare providers 2 times during your pregnancy, and within 4 weeks after your estimated delivery date, to ask about any changes in your pregnancy, general health, and treatment since the last call
• contact your baby’s healthcare provider about 4 weeks after you have given birth, and when your baby is 3, 6, and 12 months old, to ask about the health of your baby.

The contact that you and your healthcare providers will receive is summarized in the diagram below.

If you participate in the registry, you will not:

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

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