Image

Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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

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 details

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

NCT05782049

University Hospital, Clermont-Ferrand

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.