Rheumatoid Arthritis in RemissionSONORENCT02618954
Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission
A study testing Articular ultrasound in people with Rheumatoid Arthritis in Remission, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA). At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis in Remission
- What is being tested?
- Articular ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jul 2016
- 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
- Age ≥ 18 years
- PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
- Patient treated by DMARDs (disease-modifying antirheumatic drug)
- Patient in confirmed remission for less than 6 months
Who cannot join
- Patient participating simultaneously in another clinical study with blind treatment
- Patient participating simultaneously in another clinical study involving decreasing of drug dose
- Patient in post clinical study exclusion period
- patients subject to legal protection measures
- Patient unable to read French
- Pregnant or breast-feeding women
- patient treated with Rituximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.
Read more
However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
Read the detailed description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month.
The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
- Conditions
- Rheumatoid Arthritis in Remission
- Being tested
- Articular ultrasound
- Keywords
- Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk
- Medical subject headings
- Arthritis, Rheumatoid, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articular ultrasoundOther
(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint
| Study group | Role | What they receive |
|---|---|---|
| Study patient | Other | Articular ultrasound at each study follow-up Receives: Other: Articular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year pejorative evolution
Number of patient with a clinical relapse
Measured: 1 year after inclusion
Secondary outcomes (8)
Structural progression
Number of patient with a structural progression of the illness
Measured: 1 year after inclusion
RA (Rheumatoid Arthritis) remission duration
Evaluation of the remission duration (patient in both clinical and ultrasound remission)
Measured: At each follow-up (3,6,9 and 12 months after inclusion)
RA ultrasound remission duration
Evaluation of the ultrasound remission duration
Measured: At each follow-up (3,6,9 and 12 months after inclusion)
RA clinical remission duration
Evaluation of the clinical remission duration
Measured: At each follow-up (3,6,9 and 12 months after inclusion)
Clinical relapse at one year
Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data
Measured: 1 year after inclusion
Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)
identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission
Measured: At baseline
Radiographic progression at 1 year
Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis
Measured: 1 year after inclusion
Intra-observator reproductibility
Evaluating the intra-observer reliability for US synovitis through study completion
Measured: 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis in RemissionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël Mouterde, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618954
- Sponsor's protocol ID
- 9186
- Acronym
- SONORE
- Status last verified
- Jun 2018
- First submitted
- 19 Nov 2015
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
- ClinicalTrials.gov ID
- NCT02618954
- Acronym / sponsor ID
- SONORE / 9186
- Conditions
- Rheumatoid Arthritis in Remission
- Keywords
- Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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 objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.
However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
Detailed description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month.
The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patient | Other | Other: Articular ultrasoundArticular ultrasound at each study follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
- Patient treated by DMARDs (disease-modifying antirheumatic drug)
- Patient in confirmed remission for less than 6 months
Key exclusion criteria (7 listed)
- Patient participating simultaneously in another clinical study with blind treatment
- Patient participating simultaneously in another clinical study involving decreasing of drug dose
- Patient in post clinical study exclusion period
- patients subject to legal protection measures
- Patient unable to read French
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 |
|---|---|---|
| Articular ultrasound(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint | Other | Study patient |
Primary outcome
1 year pejorative evolution
Time frame: 1 year after inclusion
Number of patient with a clinical relapse
8 secondary outcomes
Structural progression
Time frame: 1 year after inclusion
RA (Rheumatoid Arthritis) remission duration
Time frame: At each follow-up (3,6,9 and 12 months after inclusion)
RA ultrasound remission duration
Time frame: At each follow-up (3,6,9 and 12 months after inclusion)
RA clinical remission duration
Time frame: At each follow-up (3,6,9 and 12 months after inclusion)
Clinical relapse at one year
Time frame: 1 year after inclusion
Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)
Time frame: At baseline
Radiographic progression at 1 year
Time frame: 1 year after inclusion
Intra-observator reproductibility
Time frame: 1 year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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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.
Gaël Mouterde, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articular ultrasound in people with Rheumatoid Arthritis in Remission, run by University Hospital, Montpellier 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 7 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: finished, as of the sponsor's last update on 11 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year pejorative evolution (time frame: 1 year after inclusion). 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 11 Jun 2018.