Belimumab (BENLYSTA®) Pregnancy Registry

June 9, 2025 updated by: GlaxoSmithKline

WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • GSK Investigational Site
  • Belgium
      • LiEge, Belgium, 4000
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, H4T 1V6
        • GSK Investigational Site
  • France
      • Paris, France, 75651
        • GSK Investigational Site
  • Germany
      • Duesseldorf, Germany, 40225
        • GSK Investigational Site
  • Israel
      • Tel Hashomer, Israel, 52621
        • GSK Investigational Site
  • Italy
      • Pisa, Italy, 56126
        • GSK Investigational Site
  • Portugal
      • Almada, Portugal, 2805-267
        • GSK Investigational Site
  • Spain
      • Bilbao, Spain, 48013
        • GSK Investigational Site
  • Sweden
      • Stockholm, Sweden, SE-17176
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • GSK Investigational Site
      • St Gallen, Switzerland, 9007
        • GSK Investigational Site
      • Zuerich, Switzerland, 8006
        • GSK Investigational Site
  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401-3331
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women taking belimumab
Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
Drug: belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
Infants
Infants through the first year of life whose mothers were exposed to belimumab during pregnancy
Drug: belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth defects
Time Frame: 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)
Up to one year after birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

PPD Development, LP

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2012

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimated)

February 14, 2012

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114256
  • WEUKBRE6076 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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