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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Diagnostic test: Positive serology for anti-SSA

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nihal Nihal MARTIS, MD, MSc; Phone Number: +33 4 92035444; Email: martis.n@chu-nice.fr

Study Locations

• France
  • Alpes-Mritimes
    • Nice, Alpes-Mritimes, France, 06000
      • Recruiting
      • CHU Nice
      • Contact: Nihal MARTIS, MD, MSc; Phone Number: +33 4 92035444; Email: martis.n@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Positive serology for anti-SSA; Blood sample which detect serology for anti-SSA.
No Intervention: Control; Control subjects will be recruited from the nursing staff of Nice University Hospital on a voluntary basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The molecular and functional impact : inflammatory cytokine and chemokine profiles	To 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.	1 year
The molecular and functional impact : cell apoptosis/survival and cellular polarization	To 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.	1 year
The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages	To 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.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Nihal MARTIS, MD, MSc, CHU Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): February 9, 2025
• Study Completion (Estimated): February 9, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular risk; Sjogren's Syndrome; protein; connective tissue disorder; Ro60
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 22-AOIP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No