Ro60 Expression in Macrophages in Sjogren's Disease

NCT06324968 | Active Not Recruiting

• 1 other identifier: 22-AOIP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• SSA/Ro60 interactions

  To 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.

  1 year

Secondary Outcomes (3)

• The molecular and functional impact : inflammatory cytokine and chemokine profiles

  1 year

• The molecular and functional impact : cell apoptosis/survival and cellular polarization

  1 year

• The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages

  1 year

Study Arms (2)

Sjögren's disease

EXPERIMENTAL

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.

Diagnostic Test: Positive serology for anti-SSA

Control

NO INTERVENTION

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

Interventions

Positive serology for anti-SSA DIAGNOSTIC_TEST

Blood sample which detect serology for anti-SSA.

Sjögren's disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Protected persons as defined in articles of the French Public Health Code.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice

Nice, Alpes-Mritimes, 06000, France

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nihal MARTIS, MD, MSc

  CHU NICE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: March 22, 2024
• Study Start: February 9, 2024
• Primary Completion: December 13, 2024
• Study Completion: May 9, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)