Moderate-to-severe Systemic Lupus Erythematosus (SLE)
Conditions
Brief summary
BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52
Detailed description
Proportion of patients who are BICLA responders at Week 52 and have maintained low (or reduced) OSC use through Week 52 maintained low (or reduced) OSC use is defined as per protocol pages 26 and 52., The time from first dose of study intervention during the Double-Blind Study Period to first BICLA response sustained through Week 52, Time to flare through Week 52 where flare is defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG 2004 B items compared to the previous visit
Interventions
DRUGAnifrolumab
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BICLA a composite binary response defined by meeting all criteria as per protocol page 25 and 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who are BICLA responders at Week 52 and have maintained low (or reduced) OSC use through Week 52 maintained low (or reduced) OSC use is defined as per protocol pages 26 and 52., The time from first dose of study intervention during the Double-Blind Study Period to first BICLA response sustained through Week 52, Time to flare through Week 52 where flare is defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG 2004 B items compared to the previous visit | — |
Countries
Bulgaria, Germany, Hungary, Poland, Spain
Outcome results
None listed