Toll free

Toll-free:

1-877-681-6296
US & Canada

Downloadable

registry materials :

Click here to complete the form and mail or fax to PPD

Download a brochure describing the Belimumab Pregnancy Registry

Frequently Asked Questions
  • What is the Belimumab Pregnancy Registry (BPR)?

    • The Belimumab Pregnancy Registry is a voluntary, observational research study.  An observational study is not an experiment.  It is a study in which researchers record health information and do not change any treatment.  This study is for women who have been given BENLYSTA within the 4 months prior to becoming pregnant and/or during pregnancy.  The Registry will help us learn more about the pregnancy outcomes of women who were given BENLYSTA within the 4 months prior to and/or during pregnancy and the health of infants born to women who were given BENLYSTA during this period.
    • There will not be any extra doctor(s) visits, tests or treatments if you take part in the Belimumab Pregnancy Registry.
    • The Belimumab Pregnancy Registry collects health information from pregnant women and their doctor(s) or healthcare provider(s).  The Belimumab Pregnancy Registry collects information about the woman’s medical condition(s) and her health during her pregnancy.  The Belimumab Pregnancy Registry also collects information about any medicine used during the pregnancy.  Information will also be collected from the baby’s doctor(s) about the baby’s health at birth and at 4 and 12 months.
  • Who can participate in the Registry?

    If you are pregnant and have been given BENLYSTA within the 4 months prior to becoming pregnant and/ or during pregnancy, you may be eligible to enroll in the Belimumab Pregnancy Registry.

    If you call the Belimumab Pregnancy Registry, a registry staff member will ask you and/or your doctor(s) a few simple questions.  Your responses will determine if you are eligible to take part in the Registry.

    1. Are you pregnant?
    2. Have you been given BENLYSTA within the 4 months prior to and/or during your pregnancy?
    3. The Belimumab Pregnancy Registry staff will contact your doctor(s) to find out about your health and your baby’s health during the time that you are taking part in the Registry. Are you able to give the registry staff member the phone number of your doctor(s) ?       

    If you answered yes to all of the above questions, please call us toll-free at 1-877-681-6296 (US & Canada).

  • What do I need to do if I would like to take part in the Registry?

    • If you agree to take part in the Belimumab Pregnancy Registry, you will give your consent for the registry staff to contact your doctor(s) and your baby’s doctor(s).  
      • You will also give your consent for your doctor(s) and your baby’s doctor(s) to give the registry information about you, your pregnancy, and your baby. 
      • You can either give your consent to one of your doctors or to Registry staff by phone.
    • With your consent, we will collect information from your doctor and your baby’s doctor(s). 
      • We will contact the doctor seeing you for this pregnancy and the doctor who gave you BENLYSTA.
      • Your baby’s doctor(s) will be contacted once your baby is born.  
    • We will ask your doctor(s) and your baby’s doctor(s) for information about your medical condition, your general health during pregnancy, and your baby’s health.  If we cannot reach these doctor(s), we may contact you.  
    • A registry staff member or your doctor(s) will help you complete the Patient Registration Form.
  • How long will I need to take part in the Registry?

    Your permission for your doctor(s) and your baby’s doctor(s) to provide information to the Belimumab Pregnancy Registry will be over once the study has ended.  If at any time or for any reason, you do not want additional information to be collected by the Belimumab Pregnancy Registry, just let us know by calling toll-free 1-877-681-6296 (US & Canada) or in writing: 

    The Belimumab Pregnancy Registry Coordination Center
    PPD, Inc
    929 North Front Street
    Wilmington, NC 28401-3331

    At your request, the Belimumab Pregnancy Registry will stop collecting information from your doctor(s) and your baby’s doctor(s).  Your decision will not change routine medical care for you or your baby.  However, the Belimumab Pregnancy Registry will be able to continue to use the information collected before you told us to stop.

  • Why should I take part in the Registry?

    There is no direct benefit to women (or to their babies) who volunteer to take part in the Belimumab Pregnancy Registry. Through the Belimumab Pregnancy Registry, more will be learned about the use of BENLYSTA prior to becoming pregnant or during pregnancy. The information could help pregnant women in the future. 

  • Additional Useful Information

 

Toll-free:

1-877-681-6296 (US & Canada)?

Downloadable

Registry Materials