Ro60 Expression in Macrophages in Sjogren's Disease

NCT ID: NCT06324968

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2025-05-09

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).

Conditions

Sjogren's Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sjögren's disease

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.

Group Type: EXPERIMENTAL

Positive serology for anti-SSA

Intervention Type: DIAGNOSTIC_TEST

Blood sample which detect serology for anti-SSA.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positive serology for anti-SSA

Blood sample which detect serology for anti-SSA.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nihal MARTIS, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

CHU Nice

Nice, Alpes-Mritimes, France

Countries

France

Other Identifiers

22-AOIP-01

Identifier Type: -

Identifier Source: org_study_id