Belimumab (BENLYSTA®) Pregnancy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Lupus, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/19/2018 |
| Start Date: | July 16, 2012 |
| End Date: | November 26, 2021 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
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.
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.
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
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