Belimumab (BENLYSTA®) Pregnancy Registry

Last updated: June 9, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

N/A

Condition

Systemic Lupus Erythematosus

Lupus

Cutaneous Lupus Erythematosus

Treatment

belimumab

Clinical Study ID

NCT01532310
114256
WEUKBRE6076
  • Female

Study 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

Inclusion Criteria:

  • Pregnant women containing sufficient evidence to confirm that exposure tocommercially supplied belimumab occurred within the 4 months prior to and/or duringpregnancy

  • Pregnant women with sufficient information to classify the pregnancy as prospectiveor retrospective (ie,whether the outcome of pregnancy was known at the time of firstcontact 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 ifinitial reporter is the pregnant woman

  • Consent provided by the pregnant woman for her participation and assent forparticipation of her infant.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 77
Treatment Group(s): 1
Primary Treatment: belimumab
Phase:
Study Start date:
July 16, 2012
Estimated Completion Date:
November 11, 2022

Connect with a study center

  • GSK Investigational Site

    La Plata, Buenos Aires B1902COS
    Argentina

    Site Not Available

  • GSK Investigational Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    St Laurent, Quebec H4T 1V6
    Canada

    Site Not Available

  • GSK Investigational Site

    Quebec, H4T 1V6
    Canada

    Site Not Available

  • GSK Investigational Site

    Paris, 75651
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 13, 75651
    France

    Site Not Available

  • GSK Investigational Site

    Duesseldorf, 40225
    Germany

    Site Not Available

  • GSK Investigational Site

    Ramat-Gan, 52621
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • GSK Investigational Site

    Pisa, 56126
    Italy

    Site Not Available

  • GSK Investigational Site

    Almada, 2805-267
    Portugal

    Site Not Available

  • GSK Investigational Site

    Bilbao, 48013
    Spain

    Site Not Available

  • GSK Investigational Site

    Stockholm, SE-17176
    Sweden

    Site Not Available

  • GSK Investigational Site

    Bern, 3010
    Switzerland

    Site Not Available

  • GSK Investigational Site

    St Gallen, 9007
    Switzerland

    Site Not Available

  • GSK Investigational Site

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Zuerich, 8006
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Zürich, 8006
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Wilmington, North Carolina 28401-3331
    United States

    Site Not Available

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