Ro60 Expression in Macrophages in Sjogren's Disease (RoMioSS)

Centre Hospitalier Universitaire de Nice

Status: Active, not recruiting

Conditions: Sjogren's Syndrome

Treatments: Diagnostic Test: Positive serology for anti-SSA

Study type: Interventional

Funder types: Other

Identifiers

NCT06324968

22-AOIP-01

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sjögren's disease

Experimental group

Description:

SSp patients followed by the Internal Medicine Department of Nice University Hospital will be offered participation in this study as part of their usual follow-up.

Treatment:

Diagnostic Test: Positive serology for anti-SSA

Control

No Intervention group

Description:

Control subjects will be recruited from the nursing staff of Nice University Hospital on a voluntary basis.