Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
NCT ID: NCT02140229
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2014-10-31
2018-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Usual care
Usual care and follow-up every 3 months
Usual care
Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
US-driven therapy
Clinical evaluation according to DAS28 + US every 3 months
US power doppler
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.
ACR/EULAR remission criteria-driven therapy
Clinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months
ACR/EULAR criteria
Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
Interventions
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US power doppler
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 care
Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
ACR/EULAR criteria
Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
Eligibility Criteria
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Inclusion Criteria
2. Disease duration ≤12 years
3. Patients of both genders above 18 years old
4. Remission according to DAS28 criteria (DAS28\<2.6) since at least 3 months
5. Treated with DMARDS and/or biologics with stable posology since at least 3 months
6. Treated with corticosteroids ≤5 mg/day (oral, local intra-articular or perfusion) since at least 3 months
7. Affiliated to a regimen of health insurance (only for French sites)
8. Having signed a consent form
9. 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
Exclusion Criteria
2. Predictable difficulties of follow-up
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Maria-Antonietta D'AGOSTINO, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rheumatology Department, Ambroise Paré Hospital
Locations
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Rheumatology Department, Ambroise Paré Hospital
Boulogne, Hauts DE Seine, France
Countries
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Central Contacts
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Maria-Antonietta D'AGOSTINO, MD, PhD
Role: CONTACT
Phone: + 33 1 49 09 56 74
Email: [email protected]
Other Identifiers
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P130401
Identifier Type: -
Identifier Source: org_study_id