B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome (BRAISES-DiaPSS)

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)

Study Overview

• Status: Recruiting
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Other: Blood, fluid, sells and urine samples

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • Recruiting
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sjögren patients; patients diagnosed Sjögren	Other: Blood, fluid, sells and urine samples; Blood, fluid, sells and urine samples will be collected.
Other: Non-Sjögren witnesses; patients diagnosed no Sjögren	Other: Blood, fluid, sells and urine samples; Blood, fluid, sells and urine samples will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 years
Number of patients with rheumatological manifestations	number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease	10 years
Number of patients with dermatological manifestations	number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease	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....	10 years
Disease evolution criteria	modification of the ESSDAI at each visit	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Anticipated): February 10, 2035
• Study Completion (Anticipated): February 10, 2035

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Autoimmune Diseases; Sjogren's Syndrome
• Other Study ID Numbers: BRAISE DiaPSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No