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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Sjogren's Syndrome; Sicca, Asthenia, Polyalgia Syndrome (SAPS); Rheumatoid Arthritis

Treatments: Other: Ultrasound of the salivary glands; Other: A Schirmer test; Other: Measurement of salivary flow

Study type: Interventional

Funder types: Other

Identifiers

NCT05782049

RBHP 2019 COUDERC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Group of case patients

Other group

Description:

1. Patients with Rheumatoid Arthritis 2. Patients with Sjögren's Syndrome

Treatment:

Other: Measurement of salivary flow

Other: Ultrasound of the salivary glands

Other: A Schirmer test

Group of control patients

Other group

Description:

Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)

Treatment:

Other: Measurement of salivary flow

Other: Ultrasound of the salivary glands

Other: A Schirmer test