Sjögren's syndrome
Conditions
Brief summary
Depletion of anti-Ro60, anti-Ro52, anti-La and rheumatoid factor B cells in blood, inflamed salivary gland and involved lymph node of patients with SjS at 3 months after initiation of Obinutuzumab compared to sampling before treatment initiation.
Detailed description
- Change from baseline in ESSDAI score at Week 12, 24 and 36 (11)., - Proportion of patients achieving ≥3 points reduction from baseline in ESSDAIscore at Week 12, 24 and 36., - Proportion of patients achieving ESSDAI<5 at Week 12, 24 and 36., - Change from baseline in PhGA of disease activity at Week 12, 24 and 36, - Change from baseline in PaGA of disease activity at Week 12, 24 and 36., - Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in ESSPRI at Week 12, 24 and 36 (11)., 1. Change from baseline in STAR, Schirmer’s test, unstimulated whole saliva secretion
Interventions
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
Sponsors
Radboud universitair medisch centrum Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depletion of anti-Ro60, anti-Ro52, anti-La and rheumatoid factor B cells in blood, inflamed salivary gland and involved lymph node of patients with SjS at 3 months after initiation of Obinutuzumab compared to sampling before treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in ESSDAI score at Week 12, 24 and 36 (11)., - Proportion of patients achieving ≥3 points reduction from baseline in ESSDAIscore at Week 12, 24 and 36., - Proportion of patients achieving ESSDAI<5 at Week 12, 24 and 36., - Change from baseline in PhGA of disease activity at Week 12, 24 and 36, - Change from baseline in PaGA of disease activity at Week 12, 24 and 36., - Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in ESSPRI at Week 12, 24 and 36 (11)., 1. Change from baseline in STAR, Schirmer’s test, unstimulated whole saliva secretion | — |
Outcome results
None listed