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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

Qualifiers

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),

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed