Primary Sjögren's SyndromeI GET DRYNCT03003572
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
An observational study of Primary Sjögren's Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Blood samples
- How many people
- 185 participants
- Where
- 8 sitesFrance
- Study dates
- 27 Mar 2018to Jun 2027
- 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: Patients with primary Sjögren's syndrome
Who may be able to join
- Primary Sjögren's syndrome according to the American-European Consensus Criteria)
- Informed and having signed the study consent form
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CH Pierre Oudot
Bourgoin, 38300
Marielle ROUX, MD
Marielle ROUX, MD
- Recruiting
CHU Estaing - Clermont Ferrand
Clermont-Ferrand, 63000
Marc RUIVARD, MD PhD
Marc RUIVARD, MD PhD
- Recruiting
CHU Grenoble Alpes
Grenoble, 38700
Laurence BOULLET, MD PhD
Laurence BOUILLET, MD PhD
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69317
Pascal SEVE, MD
Pascal SEVE, MD
- Recruiting
CH Lyon Sud
Lyon, 69495
Jean-Christophe LEGA, MD
Jean-Christophe LEGA, MD
- Not yet recruiting
Hôpital Edouard Herriot - CHU Lyon
Lyon
Arnaud HOT, MD PhD
Arnaud HOT, MD PhD
- Not yet recruiting
CHU Reims
Reims
Amélie SERVATTAZ, MD PhD
- Recruiting
Chu Saint-Etienne
Saint-Etienne, 42055
Pascal CATHEBRAS, MD PhD
Pascal CATHEBRAS, MD PhD
About this study
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).
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Blood samples
- Keywords
- Sjögren's syndrome, Immunoglobulin E, Anti-Ro/SSA, Autoimmune disease, Biomarker
- Medical subject headings
- Sjogren's Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start27 Mar 2018
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pascal CATHEBRAS, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003572
- Sponsor's protocol ID
- 1608171
- Other IDs
- ANSM
- Acronym
- I GET DRY
- Status last verified
- May 2026
- First submitted
- 22 Dec 2016
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
- ClinicalTrials.gov ID
- NCT03003572
- Acronym / sponsor ID
- I GET DRY / 1608171
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Sjögren's syndrome, Immunoglobulin E, Anti-Ro/SSA, Autoimmune disease, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Dec 2016 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with primary Sjögren's syndrome | – | Other: Blood samplesBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary Sjögren's syndrome
Key inclusion criteria (2 listed)
- Primary Sjögren's syndrome according to the American-European Consensus Criteria)
- Informed and having signed the study consent form
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA). | Other | patients with primary Sjögren's syndrome |
Primary outcome
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
6 secondary outcomes
Correlation between anti-Ro/SSA IgE titers and pSS's activity.
Time frame: Day 1
Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level
Time frame: Day 1
Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma
Time frame: 5 years
Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature
Time frame: Day 1
Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics
Time frame: Day 1
Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics
Time frame: Day 1
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 6 May 2026.
- 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.
Pascal CATHEBRAS, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren's Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Pascal CATHEBRAS, MD PhD ((0)477828342 ext. +33, pascal.cathebras@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of anti-Ro/SSA IgE positive patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.