Clinical trial NCT01532310: Belimumab (BENLYSTA®) Pregnancy Registry
Official title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
belimumab
pregnancy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2012-02-14
Enrollment: 77
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with SLE who have been exposed to commercially supplied belimumab within the 4 months prior to and/or during pregnancy will be eligible to participate in the registry as well as their infants.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Birth defects
timeFrame: Up to one year after birth
Secondary outcomes:
measure: Other pregnancy outcomes
timeFrame: At birth
measure: Infant outcomes
timeFrame: Up to 1 year after birth
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Innsbruck
country: Austria
facility: GSK Investigational Site
city: LiEge
country: Belgium
facility: GSK Investigational Site
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
city: Tel Hashomer
country: Israel
facility: GSK Investigational Site
city: Pisa
country: Italy
facility: GSK Investigational Site
city: Almada
country: Portugal
facility: GSK Investigational Site
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: St Gallen
country: Switzerland
facility: GSK Investigational Site
city: Zuerich
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. 2023 Jan 15;115(2):188-204. doi: 10.1002/bdr2.2091. Epub 2022 Sep 30.