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NCT01532310 · ClinicalTrials.gov registry record
Belimumab (BENLYSTA®) Pregnancy Registry
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 77
- Enrollment target
NCT01532310: Completed study, sponsored by GlaxoSmithKline.
NCT01532310 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532310 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DRUG belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-07-16 |
| Est. Completion | 2022-11-11 |
What the finished NCT01532310 record still lists
NCT01532310 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which belimumab is the first listed.
NCT01532310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532310 about?
NCT01532310 is a clinical study titled "Belimumab (BENLYSTA®) Pregnancy Registry". 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...
What is the current status of trial NCT01532310?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2012-07-16. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT01532310?
The interventions under investigation include: belimumab (DRUG).
Who is sponsoring clinical trial NCT01532310?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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