Belimumab (BENLYSTA®) Pregnancy Registry

Systemic Lupus Erythematosus Clinical Trial

Official title:

WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532310
• Other study ID #: 114256
• Secondary ID: WEUKBRE6076
• Status: Completed
• Start date: July 16, 2012
• Est. completion date: November 11, 2022

Study information

• Verified date: January 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• belimumab
Belimumab is a recombinant, human, IgG1? monoclonal antibody for the treatment of systemic lupus erythematosus

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	La Plata	Buenos Aires
Austria	GSK Investigational Site	Innsbruck
Belgium	GSK Investigational Site	Liège
Canada	GSK Investigational Site	St Laurent	Quebec
France	GSK Investigational Site	Paris Cedex 13
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Israel	GSK Investigational Site	Ramat-Gan
Italy	GSK Investigational Site	Pisa	Toscana
Portugal	GSK Investigational Site	Almada
Spain	GSK Investigational Site	Bilbao
Sweden	GSK Investigational Site	Stockholm
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	St. Gallen
Switzerland	GSK Investigational Site	Zürich
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	PPD

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Portugal,  Spain,  Sweden,  Switzerland, 

References & Publications (1)

Juliao P, Wurst K, Pimenta JM, Gemzoe K, Landy H, Moody MA, Tilson H, Covington D, Moore T, Marino R, Gilbride J, Liu A, Meizlik P, Petri M. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry. Birth Defects Res. 2022 Sep 30. doi: 10.1002/bdr2.2091. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to one year after birth
Secondary	Other pregnancy outcomes	Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination	At birth
Secondary	Infant outcomes	Serious and/or clinically significant infections	Up to 1 year after birth

External Links

•   Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries