Ro60 Expression in Macrophages in Sjogren's Disease

Sjogren's Syndrome Clinical Trial

— RoMioSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324968
• Other study ID #: 22-AOIP-01
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: February 9, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Nihal Nihal MARTIS, MD, MSc
• Phone: 4 92035444
• Email: martis.n[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 9, 2026
• Est. primary completion date: February 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Positive serology for anti-SSA
Blood sample which detect serology for anti-SSA.

Locations

Country	Name	City	State
France	CHU Nice	Nice	Alpes-Mritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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