Start Date
April 30, 2013
Primary Completion Date
January 31, 2014
Study Completion Date
January 31, 2014
Belimumab 10 mg
Belimumab is Lyophilised powder for reconstitution in 4.8 mL sterile water for injection (SWFI) and diluted in normal saline (250 mL). 400 mg per vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate). Belimumab 10 mg/kg intravenous infusion (will last for 1 hr) on Day 0, Week 2, Week 4, then every 4 weeks for up to 100 weeks
Placebo
Normal saline solution (sodium chloride 154 mmol/L). Intravenous infusion (will last for 1 hr) on Day 0, Week 2, Week 4, then every 4 weeks for up to 100 weeks
GSK Investigational Site, New Lambton
GSK Investigational Site, Berlin
GSK Investigational Site, Lecco
GSK Investigational Site, Chapel Hill
GSK Investigational Site, Madrid
GSK Investigational Site, Toulouse
GSK Investigational Site, Solingen
GSK Investigational Site, Valencia
GSK Investigational Site, Aachen
GSK Investigational Site, Lido Di Camaiore (LU)
GSK Investigational Site, St Louis
GSK Investigational Site, Mannheim
GSK Investigational Site, Paris
GSK Investigational Site, Amiens
GSK Investigational Site, Munich
GSK Investigational Site, Ulm
GSK Investigational Site, Créteil
GSK Investigational Site, Würzburg
GSK Investigational Site, Edmonton
GSK Investigational Site, London
GSK Investigational Site, Prague
GSK Investigational Site, Amsterdam
GSK Investigational Site, Nijmegen
GSK Investigational Site, L'Hospitalet de Llobregat
GSK Investigational Site, Cardiff
GSK Investigational Site, Gloucester
GSK Investigational Site, Leicester
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, Reading
Lead Sponsor
GlaxoSmithKline
INDUSTRY