Sjögren´s SyndromeRo-SjSNCT07414667
Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification (Ro-SjS)
An observational study of Sjögren´s Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren´s Syndrome
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Université de Nancy
Vandœuvre-lès-Nancy, 54500
Léa JACQUEL, MD, Clinical assistant, +33383153298, l.jacquel2@chru-nancy.fr
About this study
Official title: Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification
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.
Read the detailed description
Primary Sjögren's Syndrome (pSS) is a systemic autoimmune disorder characterized by lymphocytic infiltration of exocrine glands, leading to dryness symptoms, and by a wide spectrum of systemic manifestations. Autoantibodies, particularly anti-Ro/SSA antibodies, are hallmark features of the disease and play a central role in diagnosis and classification. Among these, anti-Ro52 antibodies have been increasingly recognized as a distinct immunological marker, often co-occurring with or without anti-Ro60 and anti-La antibodies.
While qualitative detection of anti-Ro52 is widely used in routine clinical practice, the clinical significance of their quantitative levels remains underexplored. Recent studies suggest that high titers of anti-Ro52 may be associated with more severe systemic disease, including pulmonary, muscular, and neurological involvement, as well as with increased interferon signature activity. However, no consensus currently exists regarding their utility as a prognostic or stratification biomarker in pSS.
This retrospective cohort study aims to assess whether quantitative anti-Ro52 antibody levels correlate with specific clinical phenotypes, immunological patterns, and long-term outcomes in patients with primary Sjögren's Syndrome. Clinical data, including organ involvement, biological markers, disease activity scores (e.g., ESSDAI), and treatment response, will be collected and analyzed in relation to anti-Ro52 titers measured by standardized quantitative assays.
The objectives are:
- To determine whether high anti-Ro52 titers are predictive of systemic involvement at baseline or during follow-up;
- To identify clusters of patients based on anti-Ro52 levels and associated clinical/immunological profiles;
- To evaluate the potential of quantitative anti-Ro52 testing as a tool for risk stratification and personalized therapeutic strategies.
This study will provide insights into the prognostic implications of anti-Ro52 in pSS and contribute to refining clinical management and follow-up of affected patients.
- Conditions
- Sjögren´s Syndrome
- Keywords
- Anti-Ro52 antibodies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Frequency of anti-Ro52 positiviy
Frequency of anti-Ro52 antibodies (presence vs absence) and quantitative distribution within the study cohort.
Measured: 2 years
Association between anti-Ro52 antibody levels and disease activity
Association between anti-Ro52 antibody levels and disease activity, using the ESSDAI score and, where applicable, biomarkers such as gammaglobulins and complement levels (C3/C4).
Measured: 2 years
Correlation between quantitative anti-Ro52 antibody levels and clinical/immunological features at baseline.
Correlation between anti-Ro52 levels (IU/mL, ELISA) and baseline clinico-biological features:
Glandular vs extraglandular involvement (binary phenotype from clinical chart),
Presence of cryoglobulinemia (% of patients, assessed by immunofixation),
Autoimmune cytopenias (% of patients with diagnosis from CRF),
Hypergammaglobulinemia (serum IgG, g/L, measured by nephelometry),
Immunoglobulin deficiency (IgG/A/M, g/L).
Statistical correlations will be assessed using Spearman or logistic regression as appropriate.
Measured: 2 years
Classification of patients into subgroups (clusters) based on anti-Ro52 levels.
Cluster-based classification of patients using anti-Ro52 levels (IU/mL, ELISA) and associated variables (clinical phenotype, immunological markers, disease course).
A data-driven clustering approach (e.g., hierarchical or k-means) will be applied to group patients. For each cluster, the following aggregated characteristics will be described: type of organ involvement (% of patients), presence of immunological markers (e.g., cryoglobulinemia, cytopenias), and indicators of disease progression (e.g., number of flares, treatment escalation).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sjögren´s SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JACQUEL Léa, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414667
- Sponsor's protocol ID
- 2025PI076
- Acronym
- Ro-SjS
- Status last verified
- Feb 2026
- First submitted
- 27 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38130019Decker 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.
PubMed 34896652
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification
- ClinicalTrials.gov ID
- NCT07414667
- Acronym / sponsor ID
- Ro-SjS / 2025PI076
- Conditions
- Sjögren´s Syndrome
- Keywords
- Anti-Ro52 antibodies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Sjögren's Syndrome (pSS) is a systemic autoimmune disorder characterized by lymphocytic infiltration of exocrine glands, leading to dryness symptoms, and by a wide spectrum of systemic manifestations. Autoantibodies, particularly anti-Ro/SSA antibodies, are hallmark features of the disease and play a central role in diagnosis and classification. Among these, anti-Ro52 antibodies have been increasingly recognized as a distinct immunological marker, often co-occurring with or without anti-Ro60 and anti-La antibodies.
While qualitative detection of anti-Ro52 is widely used in routine clinical practice, the clinical significance of their quantitative levels remains underexplored. Recent studies suggest that high titers of anti-Ro52 may be associated with more severe systemic disease, including pulmonary, muscular, and neurological involvement, as well as with increased interferon signature activity. However, no consensus currently exists regarding their utility as a prognostic or stratification biomarker in pSS.
This retrospective cohort study aims to assess whether quantitative anti-Ro52 antibody levels correlate with specific clinical phenotypes, immunological patterns, and long-term outcomes in patients with primary Sjögren's Syndrome. Clinical data, including organ involvement, biological markers, disease activity scores (e.g., ESSDAI), and treatment response, will be collected and analyzed in relation to anti-Ro52 titers measured by standardized quantitative assays.
The objectives are:
- To determine whether high anti-Ro52 titers are predictive of systemic involvement at baseline or during follow-up;
- To identify clusters of patients based on anti-Ro52 levels and associated clinical/immunological profiles;
- To evaluate the potential of quantitative anti-Ro52 testing as a tool for risk stratification and personalized therapeutic strategies.
This study will provide insights into the prognostic implications of anti-Ro52 in pSS and contribute to refining clinical management and follow-up of affected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a severe clinical event during follow-up
Time frame: 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.
4 secondary outcomes
Frequency of anti-Ro52 positiviy
Time frame: 2 years
Association between anti-Ro52 antibody levels and disease activity
Time frame: 2 years
Correlation between quantitative anti-Ro52 antibody levels and clinical/immunological features at baseline.
Time frame: 2 years
Classification of patients into subgroups (clusters) based on anti-Ro52 levels.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 38130019Bettacchioli 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.
- Background: PubMed 34896652Decker 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren´s Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léa JACQUEL, MD, Clinical assistant (+33383153298, l.jacquel2@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a severe clinical event during follow-up (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414667, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.