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Monoclonal Antibodies

Ustekinumab for Sjögren's Syndrome

Phase 1
Waitlist Available
Led By Ummara Shah, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will see if it's safe to give the drug ustekinumab to people with Primary Sjogren's Syndrome, and if it reduces inflammation.

Eligible Conditions
  • Sjögren's Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24
Secondary outcome measures
Change in serum biomarkers of inflammation from baseline to week 24
Change in the Short Form Health Survey (SF-36) Patient Reported Outcome Measure between day 0 and week 24
Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24.
+1 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

Trial Design

1Treatment groups
Experimental Treatment
Group I: UstekinumabExperimental Treatment1 Intervention
All subjects will receive an intravenous loading dose of 6 mg/kg at their baseline visit. 650mg acetaminophen and 60mg allegra will be given as premedication to the infusion. All patients will receive 90mg ustekinumab by a subcutaneous injection at all subsequent dosing visits. Subcutaneous injections do not require any premedication. Drug will be administered by qualified personnel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
2013
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
846 Previous Clinical Trials
535,089 Total Patients Enrolled
2 Trials studying Sjögren's Syndrome
26 Patients Enrolled for Sjögren's Syndrome
Ummara Shah, MDPrincipal Investigator - Assistant Professor of Medicine
University of Rochester
~1 spots leftby Jun 2025
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