Sjögren's disease
Conditions
Brief summary
Change from baseline in SSSD oral dryness score at Week 52
Detailed description
Change from baseline in SSSD summary score at Week 52, Change from baseline in ESSPRI score at Week 52, Change from baseline in sSF at Week 52, Change from baseline in PaGA NRS score at Week 52, Achieving SSSD response at week 52, Achieving ESSPRI response at week 52, Change from baseline in SSSD eye dryness score at Week 52., Change from baseline in FACIT- Fatigue score at Week 52, Change from baseline in SRQoL score at Week 52, Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) •Routine hematology and clinical chemistry laboratory test results • Vital signs
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SSSD oral dryness score at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in SSSD summary score at Week 52, Change from baseline in ESSPRI score at Week 52, Change from baseline in sSF at Week 52, Change from baseline in PaGA NRS score at Week 52, Achieving SSSD response at week 52, Achieving ESSPRI response at week 52, Change from baseline in SSSD eye dryness score at Week 52., Change from baseline in FACIT- Fatigue score at Week 52, Change from baseline in SRQoL score at Week 52, Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) •Routine hematology and clinical chemistry laboratory test results • Vital signs | — |
Outcome results
None listed