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

November 17, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Hauts DE Seine
      • Boulogne, Hauts DE Seine, France, 92104
        • Recruiting
        • Rheumatology Department, Ambroise Paré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual care
Usual care and follow-up every 3 months
Other: Usual care
Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
Experimental: US-driven therapy
Clinical evaluation according to DAS28 + US every 3 months
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.
Active Comparator: ACR/EULAR remission criteria-driven therapy
Clinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months
Other: ACR/EULAR criteria
Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
Time Frame: Up to 18 months

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 √TJC + 0.28 x √SJC + 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months
Time Frame: 18 months
18 months
Percentage of RA patients without radiographic structural progression
Time Frame: 18 months
Percentage of RA patients without radiographic structural progression (delta-Van der Heijde modified Sharp score ≤0) at 18 months.
18 months
Evolution of the RAPID score and HAQ
Time Frame: 18 months
Evolution of the RAPID (Routine Assessment of Patient Index Data score) and HAQ (Health Assessment Questionnaire).
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria-Antonietta D'Agostino, MD, PhD, Rheumatology Department, Ambroise Paré Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P130401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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