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

NCT07414667 | Not Yet Recruiting

• 1 other identifier: 2025PI076
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjögren´s Syndrome

Keywords

Anti-Ro52 antibodies

Outcome Measures

Primary Outcomes (1)

• Occurrence of a severe clinical event during follow-up

  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.

  2 years

Secondary Outcomes (4)

• Frequency of anti-Ro52 positiviy

  2 years

• Association between anti-Ro52 antibody levels and disease activity

  2 years

• Correlation between quantitative anti-Ro52 antibody levels and clinical/immunological features at baseline.

  2 years

• Classification of patients into subgroups (clusters) based on anti-Ro52 levels.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patients (≥18 years old) diagnosed with primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria. Participants must have had a quantitative measurement of anti-Ro52 antibodies performed as part of routine clinical care since 2020. Eligible patients will be followed in the internal medicine department or other participating units and must provide informed consent or non-opposition to participate. Patients with other systemic autoimmune diseases, prior organ or bone marrow transplantation, severe immunosuppression unrelated to Sjögren's syndrome, incomplete clinical or laboratory data, or under legal protection will be excluded.

You may qualify if:

• 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).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Université de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (2)

• Bettacchioli E, Saraux A, Tison A, Cornec D, Dueymes M, Foulquier N, Hillion S, Roguedas-Contios AM, Benyoussef AA, Alarcon-Riquelme ME, Pers JO, Devauchelle-Pensec V; PRECISESADS Clinical Consortium, and PRECISESADS Sjogren Consortium. Association of Combined Anti-Ro52/TRIM21 and Anti-Ro60/SSA Antibodies With Increased Sjogren Disease Severity Through Interferon Pathway Activation. Arthritis Rheumatol. 2024 May;76(5):751-762. doi: 10.1002/art.42789. Epub 2024 Feb 14.

  PMID: 38130019 BACKGROUND

• Decker P, Moulinet T, Pontille F, Cravat M, De Carvalho Bittencourt M, Jaussaud R. An updated review of anti-Ro52 (TRIM21) antibodies impact in connective tissue diseases clinical management. Autoimmun Rev. 2022 Mar;21(3):103013. doi: 10.1016/j.autrev.2021.103013. Epub 2021 Dec 9.

  PMID: 34896652 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Léa JACQUEL, MD, Clinical assistant

CONTACT

+33383153298; l.jacquel2@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docteur

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: February 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)