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

May 5, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of anti-Ro/SSA IgE positive patients
Time Frame: Day 1

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between anti-Ro/SSA IgE titers and pSS's activity.
Time Frame: Day 1

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
Time Frame: Day 1

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
Time Frame: 5 years

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
Time Frame: Day 1

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
Time Frame: Day 1

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
Time Frame: Day 1

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pascal CATHEBRAS, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1608171
  • ANSM (Other Identifier: 2025-A01697-42)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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