Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24
Study Overview
Brief 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).
Detailed 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ustekinumab
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.
Intervention: Ustekinumab (Drug)
Outcomes
Primary Outcomes
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24
Time Frame: baseline to 24 weeks
The primary endpoint is a well-established, patient reported questionnaire for use in PSS, the ESSPRI. The ESSPRI is composed of 3 scales - dryness, fatigue, and pain. Each scale is measured 0 - 10, 0 being no symptoms, 10 being maximal imaginable dryness, fatigue or pain. The total score is the mean score of the three scales which ranges from 0- 10. Baseline ESSPRI total score will be compared to week 24, end of treatment, ESSPRI total score.
Secondary Outcomes
- Change in the Short Form Health Survey (SF-36) Patient Reported Outcome Measure Between Day 0 and Week 24(baseline to 24 weeks)
- Change in Mean Serum Biomarkers of Inflammation From Baseline to Week 24(baseline to 24 weeks)
- Total Score of the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)(24 weeks.)
Investigators
Ummara Shah
Assistant Professor of Medicine
University of Rochester