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Clinical Trial Summary

This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).


Clinical Trial Description

This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjögren's Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04093531
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase Phase 1
Start date January 15, 2020
Completion date May 11, 2022

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