Belimumab (BENLYSTA®) Pregnancy Registry

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: belimumab

• Registration Number: NCT01532310
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Study Start: 2012-07-16
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

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Exclusion Criteria

• Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women taking belimumab	belimumab	Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
Infants	belimumab	Infants through the first year of life whose mothers were exposed to belimumab during pregnancy

Primary Outcome Measures

Name	Time	Method
Birth defects	Up to one year after birth	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)

Secondary Outcome Measures

Name	Time	Method
Other pregnancy outcomes	At birth	Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination
Infant outcomes	Up to 1 year after birth	Serious and/or clinically significant infections

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇭 Zürich, Switzerland