Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification (Ro-SjS)

Starting soon

Conditions studied: Sjögren´s Syndrome

In brief

This study aims to evaluate the prognostic value of quantitative anti-Ro52 antibody levels in patients with primary Sjögren's Syndrome. Anti-Ro52 antibodies are frequently detected in this autoimmune disease, but their specific role in disease stratification, systemic involvement, and long-term outcomes remains unclear. Through a prospective cohort analysis, the investigators will investigate the association between anti-Ro52 titers and clinical phenotypes, including extraglandular manifestations, immunological profiles, and disease progression. The objective is to determine whether quantitative assessment of anti-Ro52 antibodies can serve as a biomarker to refine risk stratification and guide personalized management in primary Sjögren's Syndrome.

Key facts

Study ID

NCT07414667

Run by

Central Hospital, Nancy, France

People needed

150

Starts

2026-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years at the time of inclusion,
• Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria,
• Quantitative measurement of anti-Ro52 antibodies performed as part of routine care, starting from 2020 (date of routine implementation in the laboratory),
• Documented medical follow-up in the internal medicine department (or other participating department),
• No objection to participation in research after being informed according to current regulations (record of non-opposition if applicable).

You may not qualify if…

• Presence of another systemic autoimmune connective tissue disease, including systemic lupus erythematosus, systemic sclerosis, autoimmune myositis, rheumatoid arthritis (except nonspecific arthralgia without classification criteria),
• History of solid organ or bone marrow transplantation,
• Severe immunosuppression unrelated to Sjögren's syndrome (e.g., HIV infection, ongoing chemotherapy for active hematologic malignancy),
• Incomplete or non-exploitable clinical or biological data preventing analysis of primary or secondary endpoints,
• Individuals under legal protection measures (e.g., guardianship).

Where it is running

• Université de Nancy — Vandœuvre-lès-Nancy, France

Full record on ClinicalTrials.gov

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