NCT07414667|Not Yet Recruiting
Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification (Ro-SjS)
Ro-SjS
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Ro-SjS
Sponsor study identifier
observational
150
1 country
1
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2025
Actual (reported)February 17, 2026
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Université de Nancy
Vandœuvre-lès-Nancy, 54500, France
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.
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.
First Submitted
May 27, 2025
First Posted
February 17, 2026
Study Start
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 1, 2026
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 17, 2026
Record last verified: 2026-02
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