Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity (I GET DRY)

Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).

Study Overview

• Status: Recruiting
• Conditions: Primary Sjögren's Syndrome
• Intervention / Treatment: Other: Blood samples

• Study Type: Observational
• Enrollment (Estimated): 185

Contacts and Locations

• Study Contact: Name: Pascal CATHEBRAS, MD PhD; Phone Number: +33 (0)477828342; Email: pascal.cathebras@chu-st-etienne.fr
• Study Contact Backup: Name: Florence RANCON, CRA; Phone Number: +33 (0)477120284; Email: florence.rancon@chu-st-etienne.fr

Study Locations

• France
  • Bourgoin, France, 38300
    • Not yet recruiting
    • CH Pierre Oudot
    • Contact: Marielle ROUX, MD
    • Principal Investigator: Marielle ROUX, MD
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Estaing - Clermont Ferrand
    • Contact: Marc RUIVARD, MD PhD
    • Principal Investigator: Marc RUIVARD, MD PhD
    • Sub-Investigator: Virginie RIEU, MD
    • Sub-Investigator: Vincent GROBOST, MD
  • Grenoble, France, 38700
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Laurence BOULLET, MD PhD
    • Principal Investigator: Laurence BOUILLET, MD PhD
    • Sub-Investigator: Françoise SARROT-REYNAULD, MD
    • Sub-Investigator: Alban DEROUX, MD
    • Sub-Investigator: Alexis BOCQUET, MD
    • Sub-Investigator: Aurélie MADELON, MD
  • Lyon, France, 69317
    • Recruiting
    • Hôpital de la Croix Rousse
    • Contact: Pascal SEVE, MD
    • Principal Investigator: Pascal SEVE, MD
    • Sub-Investigator: Yvan JAMILLOUX, MD
    • Sub-Investigator: Mathieu GERFAUD-VALENTIN, MD
    • Sub-Investigator: Claire BERNARD, MD
    • Sub-Investigator: Mathilde FRANÇOIS, MD
  • Lyon, France, 69495
    • Recruiting
    • CH Lyon Sud
    • Contact: Jean-Christophe LEGA, MD
    • Principal Investigator: Jean-Christophe LEGA, MD
    • Sub-Investigator: Quitterie REYNAUD, MD
    • Sub-Investigator: Isabelle DURIEU, MD
    • Sub-Investigator: Sabine MAINBOURG, MD
  • Lyon, France
    • Not yet recruiting
    • Hopital Edouard Herriot - CHU Lyon
    • Contact: Arnaud HOT, MD PhD
    • Principal Investigator: Arnaud HOT, MD PhD
    • Sub-Investigator: Cécile-Audrey DUREL, MD
  • Reims, France
    • Not yet recruiting
    • CHU Reims
    • Sub-Investigator: Amélie SERVATTAZ, MD PhD
  • Saint-Etienne, France, 42055
    • Recruiting
    • Chu Saint-Etienne
    • Sub-Investigator: Jean-Baptiste GAULTIER, MD
    • Contact: Pascal CATHEBRAS, MD PhD
    • Principal Investigator: Pascal CATHEBRAS, MD PhD
    • Sub-Investigator: Isabelle GUICHARD, MD
    • Sub-Investigator: Anne-Emmanuelle DEPINCE-BERGER, MD
    • Sub-Investigator: Thierry THOMAS, MD PhD
    • Sub-Investigator: Hubert MAROTTE, MD PhD
    • Sub-Investigator: Héloïse MUNOZ-PONS, MD
    • Sub-Investigator: Martin KILLIAN, MD
    • Sub-Investigator: Mijola LAMBERT, MD
    • Sub-Investigator: Béatrice PALLOT-PRADES, MD
    • Sub-Investigator: Karima BOUSSOUALIM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary Sjögren's syndrome

Description

Inclusion Criteria:

• Primary Sjögren's syndrome according to the American-European Consensus Criteria)
• Informed and having signed the study consent form

Exclusion Criteria:

• Secondary Sjögren's syndrome
• Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)
• Incapacity or refusal to sign the informed consent form
• Incapacity or refusal to perform the follow-up examinations required by the study
• Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion
• Has any current signs or symptoms of active infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with primary Sjögren's syndrome; Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria.	Other: Blood samples; Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of anti-Ro/SSA IgE positive patients	Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between anti-Ro/SSA IgE titers and pSS's activity.	pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI). Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.	Day 1
Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI). If ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable. If ESSPRI<5: symptomatology whose intensity felt by the patient is acceptable.	Day 1
Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma.	5 years
Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.	Day 1
Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics	Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Composite outcome of clinical and biologic characteristics is describe below. Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test. Biologic characteristics: anti-Ro/SSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes.	Day 1
Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics	Anti-La/SSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Composite outcome of clinical and biologic characteristics is describe below. Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test. Biologic characteristics: anti-La/SSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Pascal CATHEBRAS, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimated): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biomarker; Sjögren's syndrome; Autoimmune disease; Immunoglobulin E; Anti-Ro/SSA
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Autoimmune Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 1608171; ANSM (Other Identifier: 2026-A00172-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No