Table 1

Flow chart of this trial

VisitsScreeningFollow-up
Visit 1Visit 2Visit 3Visit 4–13Visit 14Visit 15
Time points−2 weeksWeek 0Week 2Week 44-week intervalWeek 48Week 52
Informed consent
Medical history
Physical examination
HbsAg
T-SPOT
BILAG
SLEDAI
PGA
SFI
Lab routine*
ANA profile
Anti-dsDNA
C3 and C4
Randomisation
Belimumab/placebo
Concomitant medication
Adverse event
  • *Includes complete blood cell count, urine routine test, hepatic and renal function, C reactive protein and erythrocyte sedimentation rate.

  • BILAG, British Isles Lupus Assessment Group; PGA, Physician’s Global Assessment of disease activity; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index; SFI, SELENA-SLEDAI Flare Index.