GSK-HGS1006-C1057

Study Sponsor: GSK

Study Title

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Medicine or Vaccine (generic name)

belimumab

Sponsor Identification Number

HGS1006-C1057

Trial Registry Identification Number(#'s)

NCT00424476

Medical Condition

Systemic Lupus Erythematosus

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=HGS1006-C1057

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

http://clinicaltrials.gov/show/NCT00424476

Link to study details on EudraCT (if available)

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

A follow-on study BEL112234 was conducted. This study was not originally sponsored by GSK. The results summary and publications are available on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT00424476. GSK reference study ID: 110752.

Date Added to this Site

February 2014