interventional
N/A
1 country
1
To analyze if Obinutuzumab induces depletion of anti-nuclear antibody producing and rheumatoid factor B cells in affected tissues of patients with SjS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2025
Actual (reported)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.
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Formulated product
Gazyvaro 1,000 mg concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Gazyvaro 1,000 mg concentrate for solution for infusion.
Named ingredient: obinutuzumab
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Radboud universitair medisch centrum Stichting
Nijmegen, 6525 GA, Netherlands
Rogier Thurlings
First Submitted
November 17, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
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