B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate

Pregnant and lactating woman

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood, fluid, sells and urine samples

    Other intervention

    Blood, fluid, sells and urine samples will be collected.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Sjögren patientsActive comparator 1 intervention
Group B: Non-Sjögren witnessesOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Inclusion

Secondary outcomes

1

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

Time frame
10 years
2

Number of patients with rheumatological manifestations

number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease

Time frame
10 years
3

Number of patients with dermatological manifestations

number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease

Time frame
10 years
4

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....

Time frame
10 years

Other outcomes

Sponsors and contacts

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