Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?

Rheumatoid Arthritis Clinical Trial

— REVECHO  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02140229
• Other study ID #: P130401
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2014
• Last updated: November 17, 2017
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maria-Antonietta D'AGOSTINO, MD, PhD
• Phone: + 33 1 49 09 56 74
• Email: maria-antonietta.dagostino[@]apr.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Remission
• Rheumatoid Arthritis

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
France	Rheumatology Department, Ambroise Paré Hospital	Boulogne	Hauts DE Seine

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pfizer

Country where clinical trial is conducted

France, 

Outcome

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