Overview

Belimumab (BENLYSTA®) Pregnancy Registry

Status:
Recruiting
Trial end date:
2021-11-26
Target enrollment:
Participant gender:
Summary
This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied 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. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
Details
Lead Sponsor:
GlaxoSmithKline
Collaborator:
PPD
Treatments:
Belimumab