Belimumab (BENLYSTA®) Pregnancy Registry

Study Overview
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Brief Summary
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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.

Official Title
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WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: belimumab


Participation Criteria
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Eligibility Criteria
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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
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women taking belimumab<br>Any women with belimumab exposure within the 4 months prior to and/or during pregnancy | Drug: belimumab<br>* Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus<br>|
| Infants<br>Infants through the first year of life whose mothers were exposed to belimumab during pregnancy | Drug: belimumab<br>* Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Serious and/or clinically significant infections | Up to 1 year after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lupus erythematosus, belimumab, pregnancy