Belimumab (Benlysta™) Pregnancy Registry

The Belimumab (Benlysta™) Pregnancy Registry is a prospective cohort study that enrolls women with Systemic lupus erythematosus (SLE) who have been given (exposed to) commercially-supplied belimumab within the 4 months prior to and/or during pregnancy. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women with SLE from the SABLE (Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus) protocol who are not exposed to belimumab.

This pregnancy registry is a global, multi-center observational study designed to evaluate birth defects, other pregnancy outcomes including: a) spontaneous miscarriage, b) live birth (pre-term birth and small for gestational age), c) stillbirth and d) elective termination, and infant outcomes through age 1 year (serious and/or clinically significant infections). Women at any stage of pregnancy can enrol in the Registry if the minimum eligibility criteria (below) are met. Obtaining information as early as possible in the pregnancy, following informed consent, is desirable. Data will be collected from the participant, the obstetric provider and the belimumab prescriber, and from pediatricians through age 1 year for live births.

Eligibility Criteria:

  • For belimumab exposed pregnant women: Sufficient evidence to confirm that exposure to commercially-supplied belimumab occurred within the 4 months prior to and/or during pregnancy OR For belimumab unexposed pregnant women: Any women who became pregnant during the SABLE protocol and was not exposed to belimumab (sufficient evidence to confirm that exposure to belimumab did not occur within 4 months prior to and / or during pregnancy)
  • Sufficient information to classify the pregnancy as prospective or retrospective (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
  • Full initial reporter (i.e., pregnant woman or health care provider) contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable health care providers if the initial reporter is the pregnant woman
  • Consent provided by the pregnant woman for her participation and assent for participation of her infant

For more information please contact PPD via the information below:

Registry Office Locations
North America
PPD, Inc.
929 North Front Street
Wilmington, NC 28401-3331
Toll-free Phone Number: 1-877-681-6296
Toll-free Fax Number: 1-855-269-6182
Email: belimumab.pregnancy@ppdi.com

Outside North America
PPD, Inc.
Kleine Kloosterstraat 23
1932 St. Stevens Woluwe
Brussels, Belgium
Free Phone Number: + 800-77776655
Free Fax Number: 1-855-269-6182
Email: belimumab.pregnancy@ppdi.com

Enrollment:

Estimated Enrollment: 500
Study Start Date: North America (USA and Canada): November 2011
Study Start Date: Europe: Estimated first quarter 2013
Estimated Primary Completion Date: Fourth quarter 2021 (Final data collection date for outcome measures)
Estimated Completion Date: Second quarter 2022

Additional resources: