Anifrolumab Pregnancy Registry
Join this study to help researchers, healthcare providers, and other patients learn about the safety of using SAPHNELO® (anifrolumab) and other SLE medications during pregnancy. A pregnancy registry is a study that collects health information from women who took prescription medication during their pregnancy.
Would you like to participate?
Contact the registry today
Am I eligible?
You may be eligible if you are:
- A resident of the United States
-
Currently pregnant or have been pregnant in the past year and:
- Have been diagnosed with Systemic Lupus Erythematosus and have taken SAPHNELO® (anifrolumab) during pregnancy or just prior to pregnancy
OR - Have been diagnosed with Systemic Lupus Erythematosus and have taken other medications than SAPHNELO® (anifrolumab) for the treatment of Systemic Lupus Erythematosus during pregnancy or just before pregnancy
- Have been diagnosed with Systemic Lupus Erythematosus and have taken SAPHNELO® (anifrolumab) during pregnancy or just prior to pregnancy
How do I participate?
Please complete the consent to contact card here and a Registry team member will contact you.
Email the Registry team with your contact information at: crganifrolumabpregnancyregistry@thermofisher.com
Call the Registry team toll-free at 1-888-337-0045 and leave your name and number (you can call at any time of the day to leave a message, your call will be returned during hours of operation: 8:30am – 5:00pm EST Monday – Friday).
What is SAPHNELO® (anifrolumab)?
SAPHNELO® (anifrolumab) is a prescription medication made by AstraZeneca and is used for the treatment of moderate to severe forms of Systemic Lupus Erythematosus in adults.
Women with Systemic Lupus Erythematosus who are planning to become pregnant, doctors and other healthcare providers in care of pregnant women with Systemic Lupus Erythematosus and their growing babies, and researchers can benefit from the information you provide to this Registry.
What can I expect if I participate?
If you are eligible and would like to participate, you will be asked to:
- Provide your informed consent (A voluntary agreement based on your awareness of potential risks and benefits. A requirement for participation in any research study)
- Provide the Registry with permission to contact your healthcare provider(s) to collect information for the study
You and your healthcare provider(s) will provide information to the Registry about your pregnancy and your baby´s health up to 1 year of age. This information can be provided by completing paper forms, via electronic consent or via short phone interviews with one the Registry team members. Only information normally documented in your medical record will be collected.
If you participate, there will be:
- No extra doctor’s visits or additional testing
- No changes to your existing healthcare provider(s) or care
You and your healthcare provider(s) will receive compensation for providing data to the registry.
What information will I have to provide if I decide to participate?
If you are eligible and would like to participate, you will be asked to provide information to the registry at enrollment, periodically throughout your pregnancy, and up to 12 months after birth:
- At enrollment, you will be asked to provide basic information about yourself (e.g., race, ethnicity, education, employment status, height, and weight) and information on the history of your pregnancies, family history of other medical conditions, and history of Systemic Lupus Erythematosus disease and severity information
- At the end of second trimester, shortly after giving birth, and at 4 and 12 months after a live birth, you will be asked to provide additional information about your pregnancy, the medications that you took during pregnancy, and the health of your baby.
You will be paid for providing data to the registry.