GSK-BEL114333

Study Sponsor: GSK

Study Title

BEL114333, a Multicenter, Continuation Study of Belimumab in subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase III study BEL113750 in Northeast Asia or completed the open-label extension of HGS1006-C1115 in Japan

Medicine or Vaccine (generic name)

belimumab

Sponsor Identification Number

BEL114333

Trial Registry Identification Number(#'s)

NCT01597622

Medical Condition

Systemic Lupus Erythematosus

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=114333

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

http://clinicaltrials.gov/show/NCT01597622

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

This is a follow-up study to BEL113750 and HGS1006-C1115. An annotated case report form is not available for this study. A blank case report form will be provided. This study is available in CDISC format.

Date Added to this Site

February 2020