Pilot Trial of Ustekinumab for Primary Sj gren's Syndrome

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    15
  • sponsor
    University of Rochester
Updated on 15 March 2021

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).

Description

This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjgren'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.

Details
Condition Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome
Treatment ustekinumab
Clinical Study IdentifierNCT04093531
SponsorUniversity of Rochester
Last Modified on15 March 2021

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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