Primary Sjögren’s Disease
Conditions
Brief summary
Change from baseline in clinESSDAI score at week 48
Detailed description
Change from baseline in ESSDAI score at week 48, Proportion of participants with low disease activity (clinESSDAI < 5) at week 48, Proportion of responders on STAR (defined as ≥ 5 points) at week 48, Change from baseline in DiSSA joint pain item at week 48, Change from baseline in DiSSA total score at week 48, Change from baseline in DiSSA sicca domain at week 48, Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48, Change from baseline in clinESSDAI score at week 24
Interventions
Sponsors
Argenx
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in clinESSDAI score at week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in ESSDAI score at week 48, Proportion of participants with low disease activity (clinESSDAI < 5) at week 48, Proportion of responders on STAR (defined as ≥ 5 points) at week 48, Change from baseline in DiSSA joint pain item at week 48, Change from baseline in DiSSA total score at week 48, Change from baseline in DiSSA sicca domain at week 48, Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48, Change from baseline in clinESSDAI score at week 24 | — |
Countries
Austria, Belgium, Bulgaria, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden
Outcome results
None listed