Clinical trial NCT05782049: Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
Official title: Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Sjogren's Syndrome
Sicca, Asthenia, Polyalgia Syndrome (SAPS)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: It's a cross-sectional case-control study. The study will include patients with rheumatoid arthritis compared to patients with Sjögren's syndrome or Sicca, Asthenia, Polyalgia syndrome (SAPS).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 10 minutes
Secondary outcomes:
measure: Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands
timeFrame: 10 minutes
measure: Surface of the submandibular salivary glands
timeFrame: 2 minutes
measure: Length and width of the parotid glands
timeFrame: 2 minutes
measure: Length of the submandibular glands
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marion Couderc
role: PRINCIPAL_INVESTIGATOR
References: