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NCT04093531 · ClinicalTrials.gov registry record · Phase 1
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
A Phase 1 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04093531: Completed Phase 1 study, sponsored by University of Rochester.
NCT04093531 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093531, a Phase 1 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 1 |
What the finished NCT04093531 record still lists
NCT04093531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Ustekinumab is the first listed.
NCT04093531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04093531 about?
NCT04093531 is a clinical study titled "Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome". 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).
What is the current status of trial NCT04093531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-01-15. Estimated completion is 2022-05-11.
What interventions are being tested in trial NCT04093531?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT04093531?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04093531's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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