Ultimate dePletion of autoReactive b cells using Obinutuzumab from sjÖgren's syndrome affected Tissues study- UPROOT study

Trial status: Authorised - 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 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.

- 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

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 10 participants