Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Sjogren's Syndrome; Sicca, Asthenia, Polyalgia Syndrome (SAPS); Rheumatoid Arthritis
• Interventions: Other: Ultrasound of the salivary glands; Other: Measurement of salivary flow; Other: A Schirmer test

• Registration Number: NCT05782049
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.

Detailed Description

The EchoPR study is an exploratory pathophysiology, cross-sectional, case-control study.

The aim is to study the echo-structure of the salivary glands of patients with RA ( group of 70 patients), in comparison to patients with SS (suspected of strong alteration of the echo-structure)(group of 70 patients) and patients with sicca, asthenia, polyalgia syndrome (SAPS)(group of 70 patients).

After a standard consultation with the rheumatologist, patients in each group will have an salivary gland ultrasound to assess the homogeneity of the echostructure of the parotid and submandibular salivary glands. A salivary flow measurement for 15 minutes and a Schirmer test to determine tear secretion for 5 minutes are also performed. All of these tests are performed during a single visit, so the total study time for the patient is one hour. Patient recruitment is expected to last 1 year.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-02-02
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-03-23
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-02-02
• Study Completion: 2026-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Patient, male or female, over 18 years of age, followed in the Rheumatology Department of the Clermont-Ferrand University Hospital, capable of giving informed consent to participate in the research.

• For RA subjects: Diagnosis of rheumatoid arthritis meeting the ACR/EULAR 2010 classification criteria.
• For SS subjects: Diagnosis of primary Sjögren's syndrome meeting the ACR/EULAR 2016 criteria.
• For SAPS subjects: Patients with dry syndrome not meeting the criteria for SS

Exclusion Criteria

• Not covered by social security
• Minors or adults under the protection of the law or under the protection of justice.
• Pregnant or breastfeeding women
• Refusal to participate
• Interference with results or classification bias: secondary causes of dry syndrome: Previous radiotherapy of the face and neck, AIDS, Hepatitis C, Sarcoidosis, Amyloidosis, Hyper-IgG4 syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group of case patients	A Schirmer test	1. Patients with Rheumatoid Arthritis 2. Patients with Sjögren's Syndrome
Group of case patients	Measurement of salivary flow	1. Patients with Rheumatoid Arthritis 2. Patients with Sjögren's Syndrome
Group of case patients	Ultrasound of the salivary glands	1. Patients with Rheumatoid Arthritis 2. Patients with Sjögren's Syndrome
Group of control patients	Measurement of salivary flow	Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)
Group of control patients	A Schirmer test	Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)
Group of control patients	Ultrasound of the salivary glands	Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)

Primary Outcome Measures

Name	Time	Method
OMERACT (Outcome Measures in Rheumatology) B-mode ultrasound homogeneity score greater than or equal to 2 in at least one of the 4 salivary glands	10 minutes	The echostructure of the gland will be graded from 0 to 4 according to the OMERACT score : * 0: normal appearance; * Grade 1: minimal inhomogeneity without hypoechoic/anechoic areas; * Grade 2: moderate inhomogeneity with focal hypoechoic or anechoic areas; * Grade 3 severe inhomogeneity with diffuse hypoechoic or anechoic areas of the whole gland or fibrous gland

Secondary Outcome Measures

Name	Time	Method
Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands	10 minutes	For each patient, 4 grades will be obtained (1 per gland); the highest grade obtained and the sum of the 4 grades will be combined.; A rating of the Doppler vascularization according to the OMERACT criteria will then be performed: * 0: no Doppler signal in the parenchyma of the gland; * 1 : focal or scattered Doppler signal in the gland parenchyma; * 2 : diffuse Doppler signal \<50% of the gland parenchyma; * 3 : diffuse Doppler signal \>50 % of the gland parenchyma
Surface of the submandibular salivary glands	2 minutes	The surface of the gland will be calculated: (length x width)/2.
Length and width of the parotid glands	2 minutes	During the ultrasound, the examination will be done bilaterally on the parotid and submandibular glands in B mode with measurement of the dimensions of the glands (length and width in the longitudinal and axial plane for the parotids, longitudinal for the submandibular)
Length of the submandibular glands	2 minutes	During the ultrasound, the examination will be done bilaterally on the parotid and submandibular glands in B mode with measurement of the dimensions of the glands (length and width in the longitudinal and axial plane for the parotids, longitudinal for the submandibular)

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France