Rheumatoid Arthritis Clinical Trial
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.
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.
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