Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
77 participants
OBSERVATIONAL
2012-07-16
2022-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women taking belimumab
Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
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
belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
Interventions
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belimumab
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
Eligibility Criteria
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Inclusion Criteria
* 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.
FEMALE
No
Sponsors
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PPD Development, LP
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Innsbruck, , Austria
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Paris, , France
GSK Investigational Site
Düsseldorf, , Germany
GSK Investigational Site
Tel Litwinsky, , Israel
GSK Investigational Site
Pisa, , Italy
GSK Investigational Site
Almada, , Portugal
GSK Investigational Site
Bilbao, , Spain
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Sankt Gallen, , Switzerland
GSK Investigational Site
Zurich, , Switzerland
Countries
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References
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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.
Related Links
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Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries
Other Identifiers
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WEUKBRE6076
Identifier Type: OTHER
Identifier Source: secondary_id
114256
Identifier Type: -
Identifier Source: org_study_id
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