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Ro60 Expression in Macrophages in Sjogren's Disease

Ro60 Expression in Macrophages in Patients with Primary Sjogren's Syndrome

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06324968
Acronym
RoMioSS
Enrollment
20
Registered
2024-03-22
Start date
2024-02-09
Completion date
2025-05-09
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome

Keywords

Sjogren's Syndrome, cardiovascular risk, Ro60, protein, connective tissue disorder

Brief summary

Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD).

Interventions

DIAGNOSTIC_TESTPositive serology for anti-SSA

Blood sample which detect serology for anti-SSA.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with SSp Subjects aged between 18 and 75, without chronic disease; Subject meeting the classification criteria for SSp; Subject with positive anti-SSA serology; French-speaking subject able to give written consent; Subject affiliated to the Sécurité Sociale or an equivalent scheme; Subject willing to have blood samples taken; * Control subjects Subjects aged between 18 and 75, without chronic disease and not meeting SSp classification criteria; Subject who understands and speaks French and is able to give written consent; Subject affiliated to the French Social Security system or an equivalent scheme; Subject willing to have blood taken;

Exclusion criteria

* Subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months; * Subject undergoing biotherapy or cytoreductive treatment; * Subjects with positive serologies for human immunodeficiency virus (HIV), viral hepatitis B virus (HBV) and viral hepatitis C virus (HCV) in the 3 months preceding the inclusion visit; * Protected persons as defined in articles of the French Public Health Code.

Design outcomes

Primary

MeasureTime frameDescription
SSA/Ro60 interactions1 yearTo evaluate whether the presence of anti-Ro60 autoantibodies causes the loss of Ro60 binding activity to genomic DNA and the TREX protein complex in PBMC. Measure the presence of anti-Ro60 autoantibodies in blood.

Secondary

MeasureTime frameDescription
The molecular and functional impact : inflammatory cytokine and chemokine profiles1 yearTo explore the molecular and functional impact of the anti-Ro60 autoantibodies in Mo/Ma to gain insights into the pathological relevance by evaluating inflammatory cytokine and chemokine profiles with using the ELISA (Enzyme Linked Immuno Sorbent Assay) technique.
The molecular and functional impact : cell apoptosis/survival and cellular polarization1 yearTo explore the molecular and functional impact of the anti-Ro60 autoantibodies in Mo/Ma to gain insights into the pathological relevance by assessing cell apoptosis/survival and cellular polarization with flow-cytometry analysis.
The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages1 yearTo explore the molecular and functional impact of the anti-Ro60 autoantibodies in Mo/Ma to gain insights into the pathological relevance by comparing clinical and biochemical phenotypes of CD14+ monocytes/macrophages by labeling with Monoclonal Antibodies then count the number of cells.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026