Examining Salivary Gland Changes in Rheumatoid Arthritis Patients
Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
This study is testing if changes in the salivary glands of people with rheumatoid arthritis can help identify those who might also have Sjogren's syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05782049 on ClinicalTrials.gov |
What this trial studies
This study investigates the echostructural characteristics of salivary glands in patients with rheumatoid arthritis (RA) to determine if there are changes indicative of Sjogren's syndrome (SS). It involves a cross-sectional, case-control design comparing 70 RA patients with 70 SS patients and 70 patients with dry syndrome. Participants will undergo a salivary gland ultrasound, salivary flow measurement, and a Schirmer test during a single visit. The study aims to enhance understanding of the relationship between RA and SS through these assessments.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of rheumatoid arthritis, primary Sjögren's syndrome, or dry syndrome.
Not a fit: Patients with secondary causes of dry syndrome or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of Sjogren's syndrome in patients with rheumatoid arthritis.
How similar studies have performed: While there is limited research specifically on echostructural changes in salivary glands in RA patients, studies on Sjogren's syndrome have shown promising results in similar assessments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Marion Couderc — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.