The BRIUMVI Pregnancy Registry

What is a Registry and why is it important?

A Pregnancy Registry is a study that collects health information from women who take prescription medications when they are pregnant. Information is also collected on the newborn babies. This information is compared with women who have not taken medications during pregnancy.

Who is eligible to participate?

Patients may be eligible if they are:

A resident of the United States
15 to 50 years old
A pregnant woman diagnosed with multiple sclerosis who has:
- Taken BRIUMVI^® (ublituximab-xiiy) during pregnancy or just prior to pregnancy (within 6 months prior to conception)
- Taken other multiple sclerosis medications during pregnancy or just prior to pregnancy*
- Not taken any multiple sclerosis medications during pregnancy

*Please note: Patients who have taken certain multiple sclerosis medications (e.g., Ocrevus^®, Kesimpta^®) prior to or during pregnancy may not be eligible to participate. The Registry Team can help determine patients’ eligibility if these medications have been taken.

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Potential Participant Contact Request Form here and a Registry Team member will contact them.

Call the Registry Team toll free at
1-877-411-4546 (hours of operation
8.30am–5.00pm EST Monday-Friday)

What is BRIUMVI (ublituximab-xiiy)?

BRIUMVI (ublituximab-xiiy) is a prescription medication made by TG Therapeutics that is used to treat multiple sclerosis in adults. It is for the treatment of relapsing forms of multiple sclerosis including:

Clinically isolated syndrome
Relapsing-remitting disease
Active secondary progressive disease

Why is this study needed?

Three-quarters of patients with multiple sclerosis are women, and up to approximately one-third of them will deliver a baby after their disease onset.¹

Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of using multiple sclerosis medications during pregnancy on pregnancy and infant outcomes.

What does participation involve?

Eligible patients and their healthcare providers will provide information to the Registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms via the website portal, or via a short phone interview with one of the Registry Team members. Only information normally documented in patients’ medical records will be collected.

There will be:

No extra doctor’s visits or additional testing
No changes to patients’ medications or care

Eligible patients and their doctors will receive compensation for providing data to the Registry.

What information is collected?

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

Maternal obstetrical history
Family history of congenital malformations
Multiple sclerosis history
Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
Maternal exposures during pregnancy
Maternal medical conditions and pregnancy complications
Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
Infant growth and development information

Healthcare provider(s) will be compensated when they submit data to the Registry.

Eligible patients will be asked to provide information to the Registry at enrollment and periodically throughout pregnancy:

At enrollment, pregnant women will be asked to provide basic demographic information (e.g., race, ethnicity, education), height and weight, and information about their history of multiple sclerosis.

Thank you for your support in recruiting potential participants.

Reference:

1. Houtchens MK, Edwards NC, Schneider G, et al. Pregnancy rates and outcomes in women with and without MS in the United States. Neurology. 2018;91(17):e1559-69.