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

NCT02140229

Last updated date
Study Location
Rheumatology Department, Ambroise Paré Hospital
Boulogne, Hauts DE Seine, 92104, France
Contact
+ 33 1 49 09 56 74

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Remission
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Pregnant women


2. Predictable difficulties of follow-up

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Advanced Information
Descriptive Information
Brief Title  ICMJE Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
Official Title  ICMJE 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?
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Rheumatoid Arthritis
  • Remission
Intervention  ICMJE
  • 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
  • Other: ACR/EULAR criteria
    Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
Study Arms  ICMJE
  • Active Comparator: Usual care
    Usual care and follow-up every 3 months
    Intervention: Other: Usual care
  • Experimental: US-driven therapy
    Clinical evaluation according to DAS28 + US every 3 months
    Intervention: Device: US power doppler
  • Active Comparator: ACR/EULAR remission criteria-driven therapy
    Clinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months
    Intervention: Other: ACR/EULAR criteria
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2014)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02140229
Other Study ID Numbers  ICMJE P130401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Maria-Antonietta D'AGOSTINO, MD, PhDRheumatology Department, Ambroise Paré Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP