Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS) (PROMISSE)

First filed Sept. 2005, updated May 2018


The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The data obtained will be analyzed and used to explore mechanisms and predictors of poor fetal outcome.

To Learn More Contact
Marta M. Guerra, MS 212-774-7361 or
Elianna Kaplowitz, AB at 212-774-7614 or identifier: NCT00198068

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Belimumab (BENLYSTA®) Pregnancy Registry (BPR) – Prospective Cohort Study of Pregnancy Outcomes Following Benlysta Exposure Within 4 Months Prior to and/or During Pregnancy

First filed February 2012, updated September 2018


This global Belimumab Pregnancy Registry will collect prospective data on pregnancies in women with systemic lupus erythematosus (SLE) who have First filed belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

To Learn More Contact
US GSK Clinical Trials Call Center at 877-379-3718 or identifier: NCT01532310