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

Sjogren's Syndrome Clinical Trial

— BRAISES-DiaPSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931160
• Other study ID #: BRAISE DiaPSS
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 10, 2035

Study information

• Verified date: April 2023
• Source: University Hospital, Brest
• Contact: Valérie Devauchelle, MD,PhD
• Phone: 33 (0) 2 98 34 72 64
• Email: valerie.devauchelle-pensec[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 10, 2035
• Est. primary completion date: February 10, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Sjogren's Syndrome
• Syndrome

Intervention

Other:
• Blood, fluid, sells and urine samples
Blood, fluid, sells and urine samples will be collected.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of patients with rheumatological manifestations	number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease	10 years
Secondary	Number of patients with dermatological manifestations	number of patients wit arthritis of more than 6 joints, parotidomegaly, intertitial lung disease	10 years
Secondary	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
Secondary	Disease evolution criteria	modification of the ESSDAI at each visit	10 years