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Belimumab (BENLYSTA®) Pregnancy Registry

This study is currently recruiting participants.
Verified August 2017 by GlaxoSmithKline
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532310
First Posted: February 14, 2012
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline
February 2, 2012
February 14, 2012
August 9, 2017
July 16, 2012
November 26, 2021   (Final data collection date for primary outcome measure)
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)
Birth defects [ Time Frame: At birth or within 1 week of 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)
Complete list of historical versions of study NCT01532310 on ClinicalTrials.gov Archive Site
  • 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
  • Infant outcomes [ Time Frame: Up to 1 year after birth ]
    Serious and/or clinically significant infections
  • Other pregnancy outcomes [ Time Frame: At birth or within 1 week of birth ]
    Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination
  • Infant outcomes [ Time Frame: Up to 1 year after birth ]
    Serious and/or clinically significant infections
Not Provided
Not Provided
 
Belimumab (BENLYSTA®) Pregnancy Registry
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.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
9 Years
Not Provided
Non-Probability Sample
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.
Systemic Lupus Erythematosus
Drug: belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
  • Pregnant women taking belimumab
    Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
    Intervention: Drug: belimumab
  • Infants
    Infants through the first year of life whose mothers were exposed to belimumab during pregnancy
    Intervention: Drug: belimumab
Not Provided
 
Recruiting
500
November 26, 2021
November 26, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States
 
 
NCT01532310
114256
WEUKBRE6076 ( Other Identifier: GSK )
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
PPD
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017