GSK-115471

Study Sponsor: GSK

Study Title

A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race with Systemic Lupus Erythematosus (SLE)

Medicine or Vaccine (generic name)

belimumab

Sponsor Identification Number

115471

Trial Registry Identification Number(#'s)

NCT01632241

Medical Condition

Systemic Lupus Erythematosus

Phase

Phase 4

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=115471

Link to study details on ClinicalTrials.gov (if available)

https://www.clinicaltrials.gov/ct2/show/NCT01632241

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2011-005672-42

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

This study is available in CDISC format.

Date Added to this Site

July 2021