Please note that this registry is now closed. 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:
Enrollment:
Estimated Enrollment: 500 Additional resources:
Complete Prescribing Information is provided in Adobe's Portable Document Format (PDF). To view these documents, you will need Adobe Acrobat Reader; if you do not have it, follow the link below to download a copy. If you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here. |
|