Systemic Lupus ErythematosusNCT01532310
Belimumab (BENLYSTA®) Pregnancy Registry
An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 15 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- belimumab
- How many people
- 77 participants
- Where
- 15 sitesin 12 countries
- Study dates
- 16 Jul 2012to 11 Nov 2022
- How long will I take part?
- 9 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
Trial locations and contacts
15 sites in 12 countries.
15 sites in 12 countries
Switzerland3 sites
GSK Investigational Site
Bern, 3010
GSK Investigational Site
Sankt Gallen, 9007
GSK Investigational Site
Zurich, 8006
United States2 sites
GSK Investigational Site
Wilmington, North Carolina, 28401-3331
GSK Investigational Site
Wilmington, North Carolina, 28401
About this study
Official title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- belimumab
- Keywords
- systemic lupus erythematosus, belimumab, pregnancy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
belimumabDrug
Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women taking belimumab | Any women with belimumab exposure within the 4 months prior to and/or during pregnancy Receives: Drug: belimumab | |
| Infants | Infants through the first year of life whose mothers were exposed to belimumab during pregnancy Receives: Drug: belimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to one year after birth
Secondary outcomes (2)
Other pregnancy outcomes
Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination
Measured: At birth
Infant outcomes
Serious and/or clinically significant infections
Measured: Up to 1 year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study start16 Jul 2012
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 9 Years
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532310
- Sponsor's protocol ID
- 114256
- Other IDs
- WEUKBRE6076
- Status last verified
- Jun 2025
- First submitted
- 2 Feb 2012
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36177676
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
- ClinicalTrials.gov ID
- NCT01532310
- Acronym / sponsor ID
- 114256
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic lupus erythematosus, belimumab, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women taking belimumab | – | Drug: belimumabAny women with belimumab exposure within the 4 months prior to and/or during pregnancy |
| Infants | – | Drug: belimumabInfants through the first year of life whose mothers were exposed to belimumab during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| belimumabBelimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus | Drug | Infants, Pregnant women taking belimumab |
Primary outcome
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)
2 secondary outcomes
Other pregnancy outcomes
Time frame: At birth
Infant outcomes
Time frame: Up to 1 year after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 36177676Juliao 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.
- Belimumab pregnancy registry/GlaxoSmithKline pregnancy registriesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 15 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Switzerland, United States, Austria, Belgium, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth defects (time frame: Up to one year after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.