Belimumab (BENLYSTA®) Pregnancy Registry
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant women taking belimumab Any women with belimumab exposure within the 4 months prior to and/or during pregnancy |
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
|
Outcome Measures
Primary Outcome Measures
- Birth defects [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)
Secondary Outcome Measures
- Other pregnancy outcomes [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 [Up to 1 year after birth]
Serious and/or clinically significant infections
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Wilmington | North Carolina | United States | 28401-3331 |
Sponsors and Collaborators
- GlaxoSmithKline
- PPD
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Belimumab pregnancy registry/GlaxoSmithKline pregnancy registries
- A patient-centric Belimumab (Benlysta) Pregnancy Registry has been created to describe study objectives, allow visitors to download registry information and read answers to frequently asked questions (FAQs).
Publications
None provided.- 114256
- WEUKBRE6076