Rheumatoid ArthritisEchoPRNCT05782049
Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
A study testing Ultrasound of the salivary glands, Measurement of salivary flow and A Schirmer test in people with Rheumatoid Arthritis and Sjogren's Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Sjogren's Syndrome, Sicca, Asthenia, Polyalgia Syndrome (SAPS)
- What is being tested?
- Ultrasound of the salivary glands, Measurement of salivary flow and A Schirmer test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2023to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Marion Couderc
About this study
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.
Read the 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.
- Being tested
- Ultrasound of the salivary glands, Measurement of salivary flow, A Schirmer test
- Medical subject headings
- Arthritis, Rheumatoid, Sjogren's Syndrome, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the salivary glandsOther
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.
Measurement of salivary flowOther
Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes
A Schirmer testOther
A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.
| Study group | Role | What they receive |
|---|---|---|
| Group of case patients | Other | 1. Patients with Rheumatoid Arthritis
2. Patients with Sjögren's Syndrome Receives: Other: Ultrasound of the salivary glands; Other: Measurement of salivary flow; Other: A Schirmer test |
| Group of control patients | Other | Patients with Sicca, Asthenia, Polyalgia Syndrome (SAPS) Receives: Other: Ultrasound of the salivary glands; Other: Measurement of salivary flow; Other: A Schirmer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (4)
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
Measured: 10 minutes
Surface of the submandibular salivary glands
The surface of the gland will be calculated: (length x width)/2.
Measured: 2 minutes
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)
Measured: 2 minutes
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)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start2 Feb 2023
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion Couderc, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782049
- Sponsor's protocol ID
- RBHP 2019 COUDERC
- Acronym
- EchoPR
- Status last verified
- Jan 2023
- First submitted
- 2 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05782049
- Acronym / sponsor ID
- EchoPR / RBHP 2019 COUDERC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group of case patients | Other | Other: Ultrasound of the salivary glands, Other: Measurement of salivary flow, Other: A Schirmer test1. Patients with Rheumatoid Arthritis 2. Patients with Sjögren's Syndrome |
| Group of control patients | Other | Other: Ultrasound of the salivary glands, Other: Measurement of salivary flow, Other: A Schirmer testPatients with Sicca, Asthenia, Polyalgia Syndrome (SAPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the salivary glandsSalivary 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. | Other | Group of case patients, Group of control patients |
| Measurement of salivary flowSaliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes | Other | Group of case patients, Group of control patients |
| A Schirmer testA strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact. | Other | Group of case patients, Group of control patients |
Primary outcome
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
Time frame: 10 minutes
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
4 secondary outcomes
Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands
Time frame: 10 minutes
Surface of the submandibular salivary glands
Time frame: 2 minutes
Length and width of the parotid glands
Time frame: 2 minutes
Length of the submandibular glands
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Couderc principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the salivary glands, Measurement of salivary flow and A Schirmer test in people with Rheumatoid Arthritis and Sjogren's Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.