Rheumatoid ArthritisREVECHONCT02140229
Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
A study testing US power doppler and ACR/EULAR criteria in people with Rheumatoid Arthritis and Remission, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse). Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Remission
- What is being tested?
- US power doppler and ACR/EULAR criteria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Dec 2018
- 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
- RA patients (ACR 2010 criteria)
- Disease duration ≤12 years
- Patients of both genders above 18 years old
- Remission according to DAS28 criteria (DAS28<2.6) since at least 3 months
- Treated with DMARDS and/or biologics with stable posology since at least 3 months
- Treated with corticosteroids ≤5 mg/day (oral, local intra-articular or perfusion) since at least 3 months
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- Affiliated to a regimen of health insurance (only for French sites)
- Having signed a consent form
- The patient is considered reliable, willing and capable of adhering to the protocol (for example, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
Who cannot join
- Pregnant women
- Predictable difficulties of follow-up
Trial locations and contacts
1 site in 1 country.
Maria-Antonietta D'AGOSTINO, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Rheumatology Department, Ambroise Paré Hospital
Boulogne, Hauts DE Seine, 92104
About this study
Official title: REVECHO Study (REmission Véritable en ECHOgraphie) Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse).
Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the duration of sustained remission and by preventing radiographic structural progression.
The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained clinical remission.
Read the detailed description
REVECHO is an international prospective multicentre simple blinded randomized study with a longitudinal follow-up of 18 months and a total study duration of 48 months. During the first visit, after having signed the consent form, Patients undergo at each visit, a clinical evaluation comprising an assessment of tender joint count (TJC), of swollen joint count (SJC), pain assessment, patient global assessment of the activity of disease, as well as a physician global assessment of the disease activity, an ultrasound examination of small and large joints by an independent physician blinded to the clinical data, and to the results of biological exams (blood sampling to assess CRP, complete blood count (CBS), and renal and hepatic functions). The clinical, biological and ultrasound assessments will be performed every 3 months.
Patients will be then randomly assigned to one of the 3 groups: 1) "Usual care group", 2) "Clinical (DAS28)-ultrasound follow-up group" (ultrasound-driven therapy) or 3) "DAS28-ACR/EULAR remission criteria group" (ACR/EULAR remission criteria-driven therapy), with a follow-up of 18 months.
Therapeutic decisions are taken by the Referring Rheumatologist. He/she will have DAS28 + US results in the group US follow-up or DAS28 + ACR/EULAR remission criteria results in the group ACR/EULAR follow-up. Therapeutic recommendations (therapeutic options, according to the randomization group, a threshold of activity will be decided by a scientific committee for increasing, stop or change therapy) will be given according to the group of randomization and based on the level of inflammation. The Referring Rheumatologist, will be free to follow or not the therapeutic advices.
In "Usual care" group, DAS28 and PDUS assessment will be performed at each time point, however, no suggestion neither DAS28 nor PDUS results will be given to the Referring Rheumatologist. The Referring Rheumatologist will be free to manage the patient as he/she thinks more appropriate.
Conventional radiography (hand and feet) will be performed at baseline and at M18 follow-up.
Centralized evaluation of radiographs will be performed by 2 independent readers, using SvH score. Radiographic progression will be defined by a change of SvH score between baseline and M18 >0.
PDUS examination will be performed every 3 months by an independent Physician in each centre, blinded to clinical, biological and radiographic data. Shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees, ankles (tibia-talar) and MTP 1 to 5 will be examined in B mode and in Power Doppler mode.
Each joint will be scored for synovitis according to the OMERACT definition and to the OMERACT scoring system (semi-quantitative score from 0 to 3 for grey scale, PD and for combined score).
Questionnaire (RAPID and HAQ) scores will be also evaluated every 3 months in each group.
- Conditions
- Rheumatoid Arthritis, Remission
- Being tested
- US power doppler, Usual care, ACR/EULAR criteria
- Keywords
- Rheumatoid Arthritis, Remission,, DAS28,, ACR/EULAR,, RAPID, Randomized study,, Longitudinal follow-up
- Medical subject headings
- Arthritis, Rheumatoid, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US power dopplerDevice
Clinical evaluation according to DAS28 and US every 3 months. US examination is realized in B and Doppler power mode for each studied joint: Ankles, shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees and MTP 1 to 5.
Usual careOther
Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
ACR/EULAR criteriaOther
Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care and follow-up every 3 months Receives: Other: Usual care |
| US-driven therapy | Experimental | Clinical evaluation according to DAS28 + US every 3 months Receives: Device: US power doppler |
| ACR/EULAR remission criteria-driven therapy | Active comparator | Clinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months Receives: Other: ACR/EULAR criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
The DAS28 (Disease Activity Score for Rheumatoid Arthritis) score is calculated on the basis of swollen joint count (SJC) and tender joint count (TJC) out of 28 (shoulder, elbow, wrist, metacarpophalangeal (MCP) I-V, proximal interphalangeal (PIP) I-V, and knee) as follows:
DAS28-CRP= 0.56 x √TJC + 0.28 x √SJC + 0.36 x Ln (CRP + 1) + 0.014 x GA + 0.96
As a result, the DAS28 index gives a value between 0 and 10, with:
- >5.1 indicating high disease activity
- 3.2-5.1 indicating moderate disease activity
- <3.2 indicating low disease activity
- <2.6 complete remission
Measured: Up to 18 months
Secondary outcomes (3)
Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months
Measured: 18 months
Percentage of RA patients without radiographic structural progression
Percentage of RA patients without radiographic structural progression (delta-Van der Heijde modified Sharp score ≤0) at 18 months.
Measured: 18 months
Evolution of the RAPID score and HAQ
Evolution of the RAPID (Routine Assessment of Patient Index Data score) and HAQ (Health Assessment Questionnaire).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Maria-Antonietta D'AGOSTINO, MD, PhD, Principal investigator, Rheumatology Department, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140229
- Sponsor's protocol ID
- P130401
- Acronym
- REVECHO
- Status last verified
- Nov 2017
- First submitted
- 7 May 2014
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVECHO Study (REmission Véritable en ECHOgraphie) Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
- ClinicalTrials.gov ID
- NCT02140229
- Acronym / sponsor ID
- REVECHO / P130401
- Conditions
- Rheumatoid Arthritis, Remission
- Keywords
- Rheumatoid Arthritis, Remission,, DAS28,, ACR/EULAR,, RAPID, Randomized study,, Longitudinal follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 May 2014 (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.
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse).
Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the duration of sustained remission and by preventing radiographic structural progression.
The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained clinical remission.
Detailed description
REVECHO is an international prospective multicentre simple blinded randomized study with a longitudinal follow-up of 18 months and a total study duration of 48 months. During the first visit, after having signed the consent form, Patients undergo at each visit, a clinical evaluation comprising an assessment of tender joint count (TJC), of swollen joint count (SJC), pain assessment, patient global assessment of the activity of disease, as well as a physician global assessment of the disease activity, an ultrasound examination of small and large joints by an independent physician blinded to the clinical data, and to the results of biological exams (blood sampling to assess CRP, complete blood count (CBS), and renal and hepatic functions). The clinical, biological and ultrasound assessments will be performed every 3 months.
Patients will be then randomly assigned to one of the 3 groups: 1) "Usual care group", 2) "Clinical (DAS28)-ultrasound follow-up group" (ultrasound-driven therapy) or 3) "DAS28-ACR/EULAR remission criteria group" (ACR/EULAR remission criteria-driven therapy), with a follow-up of 18 months.
Therapeutic decisions are taken by the Referring Rheumatologist. He/she will have DAS28 + US results in the group US follow-up or DAS28 + ACR/EULAR remission criteria results in the group ACR/EULAR follow-up. Therapeutic recommendations (therapeutic options, according to the randomization group, a threshold of activity will be decided by a scientific committee for increasing, stop or change therapy) will be given according to the group of randomization and based on the level of inflammation. The Referring Rheumatologist, will be free to follow or not the therapeutic advices.
In "Usual care" group, DAS28 and PDUS assessment will be performed at each time point, however, no suggestion neither DAS28 nor PDUS results will be given to the Referring Rheumatologist. The Referring Rheumatologist will be free to manage the patient as he/she thinks more appropriate.
Conventional radiography (hand and feet) will be performed at baseline and at M18 follow-up.
Centralized evaluation of radiographs will be performed by 2 independent readers, using SvH score. Radiographic progression will be defined by a change of SvH score between baseline and M18 >0.
PDUS examination will be performed every 3 months by an independent Physician in each centre, blinded to clinical, biological and radiographic data. Shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees, ankles (tibia-talar) and MTP 1 to 5 will be examined in B mode and in Power Doppler mode.
Each joint will be scored for synovitis according to the OMERACT definition and to the OMERACT scoring system (semi-quantitative score from 0 to 3 for grey scale, PD and for combined score).
Questionnaire (RAPID and HAQ) scores will be also evaluated every 3 months in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual care and follow-up every 3 months |
| US-driven therapy | Experimental | Device: US power dopplerClinical evaluation according to DAS28 + US every 3 months |
| ACR/EULAR remission criteria-driven therapy | Active comparator | Other: ACR/EULAR criteriaClinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- RA patients (ACR 2010 criteria)
- Disease duration ≤12 years
- Patients of both genders above 18 years old
- Remission according to DAS28 criteria (DAS28<2.6) since at least 3 months
- Treated with DMARDS and/or biologics with stable posology since at least 3 months
Key exclusion criteria (2 listed)
- Pregnant women
- Predictable difficulties of follow-up
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 |
|---|---|---|
| US power dopplerClinical evaluation according to DAS28 and US every 3 months. US examination is realized in B and Doppler power mode for each studied joint: Ankles, shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees and MTP 1 to 5. | Device | US-driven therapy |
| Usual careClinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months | Other | Usual care |
| ACR/EULAR criteriaEvaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months. | Other | ACR/EULAR remission criteria-driven therapy |
Primary outcome
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
Time frame: Up to 18 months
The DAS28 (Disease Activity Score for Rheumatoid Arthritis) score is calculated on the basis of swollen joint count (SJC) and tender joint count (TJC) out of 28 (shoulder, elbow, wrist, metacarpophalangeal (MCP) I-V, proximal interphalangeal (PIP) I-V, and knee) as follows: DAS28-CRP= 0.56 x √TJC + 0.28 x √SJC + 0.36 x Ln (CRP + 1) + 0.014 x GA + 0.96 As a result, the DAS28 index gives a value between 0 and 10, with: * >5.1 indicating high disease activity * 3.2-5.1 indicating moderate disease activity * <3.2 indicating low disease activity * <2.6 complete remission
3 secondary outcomes
Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months
Time frame: 18 months
Percentage of RA patients without radiographic structural progression
Time frame: 18 months
Evolution of the RAPID score and HAQ
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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.
Maria-Antonietta D'AGOSTINO, MD, PhD contact
Maria-Antonietta D'AGOSTINO, MD, PhD principal investigator
Rheumatology Department, Ambroise Paré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US power doppler and ACR/EULAR criteria in people with Rheumatoid Arthritis and Remission, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 2 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 20 Nov 2017. 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 Maria-Antonietta D'AGOSTINO, MD, PhD (+ 33 1 49 09 56 74, maria-antonietta.dagostino@apr.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6 (time frame: Up to 18 months). 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 20 Nov 2017.