Rheumatoid Arthritis Clinical Trial
— REVECHOOfficial 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.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | December 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. RA patients (ACR 2010 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: 1. Pregnant women 2. Predictable difficulties of follow-up |
Country | Name | City | State |
---|---|---|---|
France | Rheumatology Department, Ambroise Paré Hospital | Boulogne | Hauts DE Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 vTJC + 0.28 x vSJC + 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 |
Up to 18 months | |
Secondary | Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months | 18 months | ||
Secondary | 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. | 18 months | |
Secondary | Evolution of the RAPID score and HAQ | Evolution of the RAPID (Routine Assessment of Patient Index Data score) and HAQ (Health Assessment Questionnaire). | 18 months |
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