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Completed

NCT Number: NCT01532310

Belimumab (BENLYSTA®) Pregnancy Registry

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belimumab

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Infant outcomes

    Time frame: Up to 1 year after birth

    Serious and/or clinically significant infections

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2012
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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