Belimumab (BENLYSTA®) Pregnancy Registry

GlaxoSmithKline77 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

belimumabDRUG

Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy * Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry) * Pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable HCPs if initial reporter is the pregnant woman * Consent provided by the pregnant woman for her participation and assent for participation of her infant. Exclusion Criteria: * Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry

Locations (15)

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Innsbruck, Austria

GSK Investigational Site

Liège, Belgium

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Paris, France

GSK Investigational Site

Düsseldorf, Germany

GSK Investigational Site

Tel Litwinsky, Israel

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Almada, Portugal

...and 5 more locations

Outcomes

Primary Outcomes

Birth defects

The registry will define and code birth defects with criteria specified by Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP)

Time frame: Up to one year after birth

Secondary Outcomes

Other pregnancy outcomes

Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination

Time frame: At birth

Infant outcomes

Serious and/or clinically significant infections

Time frame: Up to 1 year after birth

Belimumab (BENLYSTA®) Pregnancy Registry

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes