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Active, Not Recruiting

NCT Number: NCT06324968

Ro60 Expression in Macrophages in Sjogren's Disease

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive serology for anti-SSA

Diagnostic Test

Blood sample which detect serology for anti-SSA.

Primary outcomes

  1. SSA/Ro60 interactions

    Time frame: 1 year

    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.

Secondary outcomes

  1. The molecular and functional impact : inflammatory cytokine and chemokine profiles

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: RoMioSS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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