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ARTICAINE HYDROCHLORIDE Clinical Trials in Sjögren's Syndrome

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In short

Clinical trials investigating ARTICAINE HYDROCHLORIDE are studying its use in people with Sjögren's syndrome. These trials mainly look at clinical research goals such as tissue changes and how they relate to patient assessments. The available trial is an interventional Phase 2 study with a small group of participants.

Key points

  • Clinical trial data for ARTICAINE HYDROCHLORIDE shows one Phase 2 interventional study in people with Sjögren's syndrome. The study enrolled 20 participants and was completed. Researchers mainly measured changes in salivary gland tissue, especially the B/B+T cell ratio at Week 25. The trial also looked at how these tissue changes relate to clinical assessments. The data provided does not include broader details about who could join beyond the small study group.

Trial overview

The available trial for ARTICAINE HYDROCHLORIDE is NCT05124925, a completed study in people with Sjögren's syndrome. The study title says it was designed to understand changes in salivary gland tissue and explore how those changes relate to clinical assessments.

The trial data lists ARTICAINE, COMBINATIONS as one of the study interventions, alongside other drugs in the same study record. The source data does not provide more detail on the role of ARTICAINE HYDROCHLORIDE within the full treatment plan.

Study design and phase

This was an interventional study, which means researchers gave study treatments and then measured the results. It was a Phase 2 trial, a stage that usually focuses on early testing of whether a treatment has the expected effect in a smaller group of people.

The trial was completed and enrolled 20 participants. Because the study was small, its findings are meant to help researchers learn more about the treatment and the disease, not to give a final answer for all patients.

Participants and target population

The target population in this trial was people with Sjögren's syndrome. The source data does not list extra entry rules such as age range, sex, or disease severity.

The study record only shows the total enrollment number, which was 20 participants. This means the trial was focused on a small patient group, likely to look closely at tissue and clinical changes.

Main outcomes being measured

The primary outcome was the change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (end of treatment). In simple terms, the researchers measured how immune cells in the salivary gland changed over time compared with the start of the study.

This outcome is a form of histopathology, which means studying tissue under a microscope. The study title also says the researchers wanted to explore relationships with clinical assessments, meaning they wanted to see whether tissue changes matched changes seen during patient checks.

What the study aimed to learn

The brief summary says the study was designed to investigate changes in salivary gland histopathology after treatment with ianalumab. That means the main goal was to see whether treatment was linked to changes in gland tissue, not just symptom reports.

For patients, this kind of trial helps researchers connect what they see in tissue samples with what happens in the clinic. The available record does not report detailed results, so the main value of the source data is in showing the study question, phase, population, and main measurement.

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