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NCT Number: NCT04931160

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

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)

Recruiting

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Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest

Brest, France

Location status: Recruiting

Location contact

Valérie DEVAUCHELLE

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Refusal to participate
  • Pregnant and lactating woman

Treatment and study plan

Blood, fluid, sells and urine samples

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease

  2. Number of patients with rheumatological manifestations

    Time frame: 10 years

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

  3. Number of patients with dermatological manifestations

    Time frame: 10 years

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

  4. Description diagnostic performance of new tests

    Time frame: 10 years

    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....

  5. Disease evolution criteria

    Time frame: 10 years

    modification of the ESSDAI at each visit

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie Devauchelle, MD,PhD

CONTACT

[email protected]

33 (0) 2 98 34 72 64

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: BRAISES-DiaPSS

Important dates

Study start
2020
Primary completion
2035
Study completion
2035
First posted
Jun 18, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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