Systemic lupus erythematosus (SLE)
Conditions
Brief summary
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
Detailed description
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24, Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12, Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48, Achievement of LLDAS in ≥50% of post Baseline visits through Week 48, Change from Baseline in SLEDAI-2K at Week 48, Achievement of BILAG 2004 improvement without worsening at Week 48, Change from Baseline in PGA at Week 48, Achievement of SRI 4 response at Week 48, Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48, Time to severe BILAG flare through Week 48, Time to moderate/severe BILAG flare through Week 48, Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, Percentage of participants with serious treatment-emergent adverse events during the study, Percentage of participants with treatment-emergent adverse events of special interest during the study, Percentage of participants with treatment-emergent adverse events of special monitoring during the study
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24, Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12, Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48, Achievement of LLDAS in ≥50% of post Baseline visits through Week 48, Change from Baseline in SLEDAI-2K at Week 48, Achievement of BILAG 2004 improvement without worsening at Week 48, Change from Baseline in PGA at Week 48, Achievement of SRI 4 response at Week 48, Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48, Time to severe BILAG flare through Week 48, Time to moderate/severe BILAG flare through Week 48, Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, Percentage of participants with se | — |
Countries
Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Spain