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| ID | Type | Description | Link |
|---|---|---|---|
| WEUKBRE6076 | Other Identifier | GSK |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women taking belimumab | Any women with belimumab exposure within the 4 months prior to and/or during pregnancy |
| |
| Infants | Infants through the first year of life whose mothers were exposed to belimumab during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belimumab | Drug | Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other pregnancy outcomes | Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination | At birth |
| Infant outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilmington | North Carolina | 28401-3331 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36177676 | Background | 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. |
| Label | URL |
|---|---|
| Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
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Serious and/or clinically significant infections
| Up to 1 year after birth |
| Wilmington |
| North Carolina |
| 28401 |
| United States |
| GSK Investigational Site | Innsbruck | 6020 | Austria |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Québec | Quebec | H4T 1V6 | Canada |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Düsseldorf | 40225 | Germany |
| GSK Investigational Site | Tel Litwinsky | 52621 | Israel |
| GSK Investigational Site | Pisa | 56126 | Italy |
| GSK Investigational Site | Almada | 2805-267 | Portugal |
| GSK Investigational Site | Bilbao | 48013 | Spain |
| GSK Investigational Site | Stockholm | SE-17176 | Sweden |
| GSK Investigational Site | Bern | 3010 | Switzerland |
| GSK Investigational Site | Sankt Gallen | 9007 | Switzerland |
| GSK Investigational Site | Zurich | 8006 | Switzerland |