Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis (EchoPR)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Marion Couderc

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group of case patients; Patients with Rheumatoid Arthritis; Patients with Sjögren's Syndrome	Other: Ultrasound of the salivary glands; Salivary gland ultrasound is, a non-invasive, non-irradiating and easily accessible examination, offers promising results for the diagnosis of primary SS. It allows the identification of changes in the homogeneity of the echostructure of the main salivary glands in the parotid and submandibular region.The patient lies on the examination table with the head slightly turned to the side opposite the gland being examined. The examination will be done on the parotid and submandibular glands on both sides.The parotid glands will be measured in length and width.The surface of the gland will be calculated: (length x width)/2.The sub-maxillary glands will be measured in length and surface. The exam will be performed in 10 minutes.; Other: Measurement of salivary flow; Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes; Other: A Schirmer test; A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.
Other: Group of control patients; Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)	Other: Ultrasound of the salivary glands; Salivary gland ultrasound is, a non-invasive, non-irradiating and easily accessible examination, offers promising results for the diagnosis of primary SS. It allows the identification of changes in the homogeneity of the echostructure of the main salivary glands in the parotid and submandibular region.The patient lies on the examination table with the head slightly turned to the side opposite the gland being examined. The examination will be done on the parotid and submandibular glands on both sides.The parotid glands will be measured in length and width.The surface of the gland will be calculated: (length x width)/2.The sub-maxillary glands will be measured in length and surface. The exam will be performed in 10 minutes.; Other: Measurement of salivary flow; Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes; Other: A Schirmer test; A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands	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	10 minutes
Surface of the submandibular salivary glands	The surface of the gland will be calculated: (length x width)/2.	2 minutes
Length and width of the parotid glands	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)	2 minutes
Length of the submandibular glands	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)	2 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Marion Couderc, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Anticipated): February 2, 2025
• Study Completion (Anticipated): February 2, 2026

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Arthritis; Arthritis, Rheumatoid; Sjogren's Syndrome; Asthenia
• Other Study ID Numbers: RBHP 2019 COUDERC

Drug and device information, study documents

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