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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound of the salivary glands
Measurement of salivary flow
A Schirmer test
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group of case patients

Group of control patients

Arm Description

Patients with Rheumatoid Arthritis Patients with Sjögren's Syndrome

Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Surface of the submandibular salivary glands
The surface of the gland will be calculated: (length x width)/2.
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)
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)

Full Information

First Posted
March 2, 2023
Last Updated
March 22, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05782049
Brief Title
Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
Acronym
EchoPR
Official Title
Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
February 2, 2025 (Anticipated)
Study Completion Date
February 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Sjogren's Syndrome, Sicca, Asthenia, Polyalgia Syndrome (SAPS)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of case patients
Arm Type
Other
Arm Description
Patients with Rheumatoid Arthritis Patients with Sjögren's Syndrome
Arm Title
Group of control patients
Arm Type
Other
Arm Description
Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS)
Intervention Type
Other
Intervention Name(s)
Ultrasound of the salivary glands
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Measurement of salivary flow
Intervention Description
Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes
Intervention Type
Other
Intervention Name(s)
A Schirmer test
Intervention Description
A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands
Description
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
Time Frame
10 minutes
Title
Surface of the submandibular salivary glands
Description
The surface of the gland will be calculated: (length x width)/2.
Time Frame
2 minutes
Title
Length and width of the parotid glands
Description
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)
Time Frame
2 minutes
Title
Length of the submandibular glands
Description
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)
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Couderc
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Marion Couderc

12. IPD Sharing Statement

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Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

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