Belimumab (BENLYSTA®) Pregnancy Registry
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01532310
First received: February 2, 2012
Last updated: August 16, 2016
Last verified: August 2016
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Purpose
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 | Intervention |
|---|---|
|
Systemic Lupus Erythematosus |
Drug: belimumab |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 9 Years |
| Official Title: | WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic lupus erythematosus
MedlinePlus related topics:
Lupus
Drug Information available for:
Belimumab
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Birth defects [ Time Frame: Up to one year after birth ] [ Designated as safety issue: Yes ]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 [ Time Frame: At birth ] [ Designated as safety issue: Yes ]Other pregnancy outcomes including spontaneous miscarriage, live birth (including pre-term birth and small for gestational age), stillbirth, and elective termination
- Infant outcomes [ Time Frame: Up to 1 year after birth ] [ Designated as safety issue: Yes ]Serious and/or clinically significant infections
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | November 2021 |
| Estimated Primary Completion Date: | November 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532310
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532310
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, North Carolina | |
| GSK Investigational Site | Recruiting |
| Wilmington, North Carolina, United States, 28401-3331 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
PPD
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01532310 History of Changes |
| Other Study ID Numbers: | 114256 WEUKBRE6076 |
| Study First Received: | February 2, 2012 |
| Last Updated: | August 16, 2016 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Europe: European Medicines Agency |
Keywords provided by GlaxoSmithKline:
|
systemic lupus erythematosus belimumab pregnancy |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Belimumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016