Sjogren's SyndromeBRAISES-DiaPSSNCT04931160
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
A study testing Blood, fluid, sells and urine samples in people with Sjogren's Syndrome, run by University Hospital, Brest at 1 site in France.
Trial summary
The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Blood, fluid, sells and urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 10 Feb 2035
- Phase
- Interventional
- 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
Who may be able to join
- Major patient
- Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)
- Patient affiliated with Social Security
- Patient who has signed written informed consent
Who cannot join
- Refusal to participate
- Pregnant and lactating woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)
Read the detailed description
The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.
- Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.
- Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.
- Conditions
- Sjogren's Syndrome
- Being tested
- Blood, fluid, sells and urine samples
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, fluid, sells and urine samplesOther
Blood, fluid, sells and urine samples will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Sjögren patients | Active comparator | patients diagnosed Sjögren Receives: Other: Blood, fluid, sells and urine samples |
| Non-Sjögren witnesses | Other | patients diagnosed no Sjögren Receives: Other: Blood, fluid, sells and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.
Measured: Inclusion
Secondary outcomes (5)
Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Measured: 10 years
Number of patients with rheumatological manifestations
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Measured: 10 years
Number of patients with dermatological manifestations
number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease
Measured: 10 years
Description diagnostic performance of new tests
after evaluation of all différents test performed added to the classical items of the ACR 2017: ie ultrasound parenchymal abnormalities, sub population of B cells....
Measured: 10 years
Disease evolution criteria
modification of the ESSDAI at each visit
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start10 Feb 2020
- Primary completion10 Feb 2035 (estimated)
- Study completion10 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Sjögren patients * Non-Sjögren controls (retrospective)
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Devauchelle, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931160
- Sponsor's protocol ID
- 29BRC19.0091
- Acronym
- BRAISES-DiaPSS
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT04931160
- Acronym / sponsor ID
- BRAISES-DiaPSS / 29BRC19.0091
- Conditions
- Sjogren's Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2035 (estimated)
- Study completion
- 10 Feb 2035 (estimated)
- First posted
- 18 Jun 2021 (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.
The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)
Detailed description
The formation of this patient is single-center prospective intervention. It consists of collecting data from patients suspected of pSS from standardized biological clinical data and imaging examination and additional pathology.
- Sjögren patients will be followed at inclusion, 2y, 3y, 4y, 6y, 8y and 10 years. Blood, fluid, sells and urine samples will be collected at inclusion, 4y et 10y.
- Non-Sjögren controls will be followed at inclusion and 4y and samples will be collected at the same visits.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Sjögren patients * Non-Sjögren controls (retrospective)
| Arm | Type | Receives |
|---|---|---|
| Sjögren patients | Active comparator | Other: Blood, fluid, sells and urine samplespatients diagnosed Sjögren |
| Non-Sjögren witnesses | Other | Other: Blood, fluid, sells and urine samplespatients diagnosed no Sjögren |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)
- Patient affiliated with Social Security
- Patient who has signed written informed consent
Key exclusion criteria (2 listed)
- Refusal to participate
- Pregnant and lactating woman
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, fluid, sells and urine samplesBlood, fluid, sells and urine samples will be collected. | Other | Non-Sjögren witnesses, Sjögren patients |
Primary outcome
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria)
Time frame: Inclusion
Specificity of different classification criteria, the standard gold being the diagnosis obtained by consensus of expert doctors after standardized assessment.
5 secondary outcomes
Number of patients with different manifestation including in the ESSDAI (Eular Sjögren Syndrome Disease Activity index), gold standard to measure
Time frame: 10 years
Number of patients with rheumatological manifestations
Time frame: 10 years
Number of patients with dermatological manifestations
Time frame: 10 years
Description diagnostic performance of new tests
Time frame: 10 years
Disease evolution criteria
Time frame: 10 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 26 Jun 2026.
Related trials for Sjogren's Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
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.
Valérie Devauchelle principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, fluid, sells and urine samples in people with Sjogren's Syndrome, run by University Hospital, Brest 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 4 inclusion and 2 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 26 Jun 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 Valérie Devauchelle, MD,PhD (33 (0) 2 98 34 72 64, valerie.devauchelle-pensec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description specificity of different classification criteria FOR sJOGREN (EULAR/ACR 2019, european criteria) (time frame: Inclusion). 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 26 Jun 2026.