Belimumab (BENLYSTA®) Pregnancy Registry
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ClinicalTrials.gov Identifier: NCT01532310 |
Recruitment Status :
Recruiting
First Posted : February 14, 2012
Last Update Posted : February 25, 2022
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Condition or disease | Intervention/treatment |
---|---|
Systemic Lupus Erythematosus | Drug: belimumab |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 9 Years |
Official Title: | WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol |
Actual Study Start Date : | July 16, 2012 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | October 31, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Pregnant women taking belimumab
Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
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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 |
- 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)
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532310
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, North Carolina | |
GSK Investigational Site | Recruiting |
Wilmington, North Carolina, United States, 28401-3331 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Laura McKain |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01532310 |
Other Study ID Numbers: |
114256 WEUKBRE6076 ( Other Identifier: GSK ) |
First Posted: | February 14, 2012 Key Record Dates |
Last Update Posted: | February 25, 2022 |
Last Verified: | February 2022 |
systemic lupus erythematosus belimumab pregnancy |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Belimumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |