Belimumab (BENLYSTA®) Pregnancy Registry

NCT01532310 | Completed

• 2 other identifiers: 114256WEUKBRE6076
• Study Type: observational
• Target: 77
• Locations: 12 countries
• Sites: 15

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.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; belimumab; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Other pregnancy outcomes

  At birth

• Infant outcomes

  Up to 1 year after birth

Study Arms (2)

Pregnant women taking belimumab

Any women with belimumab exposure within the 4 months prior to and/or during pregnancy

Drug: belimumab

Infants

Infants through the first year of life whose mothers were exposed to belimumab during pregnancy

Drug: belimumab

Interventions

belimumab DRUG

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

Infants; Pregnant women taking belimumab

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• PPD Development, LP: collaborator

Study Sites (15)

GSK Investigational Site

Wilmington, North Carolina, 28401-3331, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Innsbruck, 6020, Austria

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Québec, Quebec, H4T 1V6, Canada

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Düsseldorf, 40225, Germany

Location

GSK Investigational Site

Tel Litwinsky, 52621, Israel

Location

GSK Investigational Site

Pisa, 56126, Italy

Location

GSK Investigational Site

Almada, 2805-267, Portugal

Location

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Stockholm, SE-17176, Sweden

Location

GSK Investigational Site

Bern, 3010, Switzerland

Location

GSK Investigational Site

Sankt Gallen, 9007, Switzerland

Location

GSK Investigational Site

Zurich, 8006, Switzerland

Location

Related 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. 2023 Jan 15;115(2):188-204. doi: 10.1002/bdr2.2091. Epub 2022 Sep 30.

  PMID: 36177676 BACKGROUND

Related Links

• Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 14, 2012
• Study Start: July 16, 2012
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

AU (1); FR (1); IT (1); CA (1); CH (3); BE (1); US (2); DE (1); IL (1); PT (1); ES (1); SE (1)