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Toll-free:

1-877-681-6296
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registry materials :

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Download a brochure describing the Belimumab Pregnancy Registry

About the Belimumab Pregnancy Registry

About the Belimumab Pregnancy Registry

The Belimumab (BENLYSTA) 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 Belimumab (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...

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The Belimumab (BENLYSTA) 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 Belimumab Pregnancy Registry will help us learn more about the pregnancy outcomes of 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.

If you agree to take part in the Registry, you will give your consent for the Belimumab Pregnancy Registry 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 Belimumab Pregnancy Registry information about you, your pregnancy, and your baby. You can either give your consent to one of your doctors or to Belimumab Pregnancy Registry staff by phone.

With your consent, we will collect information from your doctor(s) and your baby’s doctor(s). We will contact the doctor seeing you for this pregnancy.  We will also contact the doctor that 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.  We will ask that you give us this information. We may also ask for your help in getting your doctor(s) to give information to 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 Belimumab Pregnancy 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 the above questions and want to participate in the Belimumab Pregnancy Registry, you may contact us in one of the following ways:

  1. Contact the Registry by calling toll-free 1-877-681-6296 (US & Canada) to speak to a Belimumab Pregnancy Registry representative.
  2. Ask your doctor(s) to help you enroll in the Belimumab Pregnancy Registry by calling toll-free 1-877-681-6296 (US & Canada) or follow instructions listed on the following webpage:
     http://pregnancyregistry.
    gsk.com/belimumab.html

Possible Risks and Discomforts

There are no known risks with taking part in the Belimumab Pregnancy Registry. Some questions we ask will be personal. You may not feel comfortable answering some questions. If you feel very uncomfortable about a question, you do not need to answer it.

Potential Benefits

You will not receive a direct benefit from participating in the Belimumab Pregnancy Registry; however, your participation may help other women and their babies in the future. Through the Belimumab Pregnancy Registry, we will have learned more about the safety of using BENLYSTA prior to becoming pregnant or during pregnancy. This information could help you if you decide to get pregnant again.

Alternatives

You do not have to take part in the Belimumab Pregnancy Registry. Your decision will not change routine medical care for you and your baby. If you decide to participate in the Belimumab Pregnancy Registry, your consent to take part will not end unless you withdraw it. If at any time you do not want to be in the Belimumab Pregnancy Registry, just let us know by calling toll-free 1-877-681-6296 (US & Canada).

Additional Questions

When you take part in a research study like the Belimumab Pregnancy Registry you have rights. If you have questions about the Belimumab Pregnancy Registry or your rights as a study participant, call us toll-free at 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

Information about the study can also be found on  ClinicalTrials.gov, a publicly available study database.

 

Toll-free:

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

Downloadable

Registry Materials