About the OCREVUS Pregnancy Registry
The OCREVUS Pregnancy Registry is a global observational registry of women 18 years or older with MS who are pregnant and have received OCREVUS® (ocrelizumab). This registry commenced in 2019. The goal is to enroll 290 ocrelizumab-exposed women, to observe 153 pregnancy outcomes. In addition, the internal comparator group will enroll approximately 290 pregnant women to support the study objective to compare the outcomes of the ocrelizumab-exposed women with the outcomes of non-exposed women.
Internal comparator patients will be enrolled from the same sites as the ocrelizumab-exposed women and follow the same study procedures for follow-up and data collection. The internal comparator group will consist of currently pregnant women with MS who were not exposed to any MS DMTs during the 6 months prior to their LMP or at any time during pregnancy (apart from glatiramer acetate [e.g. Copaxone®] exposure through the first trimester).
It is hoped that this registry will help healthcare professionals to better understand if OCREVUS® has any effect on pregnancy, delivery, or the health of infants, since women may have taken OCREVUS® before realizing they were pregnant.
The OCREVUS Pregnancy Registry is listed on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Have questions?
Have questions?
Please call a registry representative at
1-(833)-872-4370 for more information.
Patient eligibility criteria
Your patient is potentially eligible to participate in this registry if she is 18 years or older and pregnant, has MS, and:
OR
What are my responsibilities as a healthcare provider (HCP)?
As the HCP of a study participant, you will be contacted:
- When your patient enrolls
- During your patient’s second trimester (at approximately 21 weeks)
- About 4 weeks after your patient’s expected date of delivery
As the HCP of a participant’s infant, you will be contacted when the infant is about:
- 1 month old
- 3 months old
- 6 months old
- 12 months old
At each contact point, you or your staff will be requested to:
The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.
What will my patient have to do once she is enrolled?
If your patient consents and is eligible to take part, she will be asked to share information about herself, her health and her pregnancy, and will be contacted:
- at enrollment
- during each trimester
- within 4 weeks of her estimated date of delivery, following her infant’s birth
- when her infant is 3, 6, and 12 months old
At each time point, your patient will be asked to confirm her contact information.
Will I be compensated for my time as a healthcare provider?
You may be compensated for the time you spend on providing the information. The information that you provide will help us learn more about the possible effects of OCREVUS on pregnancy, delivery, and the health of infants whose mothers were exposed to OCREVUS during pregnancy. In the future, it is hoped that the results of the registry will help you and your colleagues, along with your patients, make more informed decisions about the use of OCREVUS.
How will the registry data be collected and stored?
Women who join the OCREVUS Pregnancy Registry will provide a release of information form that will allow the Registry Coordinating Center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of their infant.
The Registry Coordinating Center will collect the information provided by the patient along with the forms submitted from the healthcare providers. The data collected from all parties will be kept in a secure database as per our privacy policy. The health information of the patient and of their infant will be kept anonymous and any identifying information will not be used.
Resources
When asked by the Registry Coordinating Center (RCC), please download, complete, and submit the applicable worksheet for your patient by fax 1-(833)-990-1135 or email it to ocrevuspregnancyregistry@iqvia.com.
For the latest important safety information, please refer to the full Prescribing Information and Medication Guide. This is not intended to replace discussions with your healthcare provider.