Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT04093531
Phase
PHASE1
Status
Completed

Conditions

  • Primary Sjögren Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    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 Details

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).

Key Dates

Start date
Jan 15, 2020
Status verified
Jun 2024
Primary completion
May 11, 2022
Completion
May 11, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642-

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By research site
University of Rochester· Rochester, NY

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