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Clinical Trials in France / NCT07414667
Starting soon Observational

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

NCT07414667 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Observational
Started
2026-06-01
Last updated
2026-02-17

Condition(s) studied

Sjögren´s Syndrome

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria : * 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). Exclusion Criteria * 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).

Primary outcome measure(s)

  • Occurrence of a severe clinical event during follow-up — 2 years
    Occurrence of a severe clinical event during follow-up, defined as the first occurrence of any of the following: Death (any cause), Histologically confirmed lymphoma, Severe organ involvement (e.g., glomerulonephritis, interstitial lung disease requiring immunosuppression, autoimmune CNS/PNS involvement, systemic vasculitis), Persistently high disease activity, defined as an ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) score ≥ 5 for ≥12 consecutive months. ESSDAI ranges from 0 to 123; higher scores indicate worse disease activity.

Trial sites (1)

FacilityCityRegionStatus
Université de Nancy Vandœuvre-lès-Nancy France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07414667 on ClinicalTrials.gov ↗ ← All trials in France