Ultrasound Evaluation of Remission in Rheumatoid Arthritis (EVER-1)

October 7, 2016 updated by: University Hospital, Grenoble

Agreement Between Disease Activity and Ultrasound Scoring (Naredo-12) in Patients With Rheumatoid Arthritis With Clinical Remission in Daily Practice.

Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.

Study Overview

Status

Completed

Conditions

Detailed Description

Clinical remission is now a realistic goal in managing rheumatoid arthritis (RA) with treat to target strategy assessed according to different composite scores (DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR-EULAR 2011 for remission). There are, however, no validated ultrasound remission criteria because of continuing uncertainty on the signification of persistent synovial hypertrophy in B-mode or Power Doppler (PD) mode in RA patients in clinical remission.

The objective was to evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.

This french multicenter cross-sectional study took place in 11 rheumatology departments. The inter and intra-observer reproducibility for the ultrasound scoring was good to excellent. Inclusion criteria were as follows: RA meeting ACR-EULAR criteria, <15 years of progression, DAS-28-ESR<2.6 for at least 3 months, with a stable treatment including corticoids if necessary (equivalent prednisone<0.1 mg/kg) for 6 months. A standardized US examination was performed by an experience ultrasonographist blinded to clinical data. Spearman's correlation coefficients were determined between the Naredo12 B-mode (min-max,0-36), PD mode (0-36) and PDUS (0-36) scores and the different clinical remission scores. The impact of disease duration or duration of the clinical remission on ultrasound scores was also assessed (Kruskall-Wallis's test).

Study Type

Observational

Enrollment (Actual)

225

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Rheumatoid Arthritis in Routine Care

Description

Inclusion Criteria:

  • Adults (âged of 18 or more),
  • Rheumatoid arthritis according to ACR-EULAR 2010 criteria, during less than 10 years at least
  • Remission according to DAS28-VS (<2.6) since 3 months at least,
  • Disease modifying anti-rheumatic drugs and/or biotherapy stable dose since 6 months at least
  • Steroids ≤0.1 mg/kg/day without high dose during the last 3 months
  • Oral and written information and consent

Exclusion Criteria:

  • Patient participating to a clinical trial about rheumatoid arthritis treatment
  • Patient under administrative supervision

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI)
Time Frame: august 2015-april 2016
Composit outcome measure : Ultrasonography score PD mode (0-36) Disease activityscore DAS28-ESR (0-10) Disease activity score DAS28-CRP (0-10) Disease activity score SDAI (0-86) Disease activity score CDAI (0-76)
august 2015-april 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI).
Time Frame: august 2015-april 2016
Composit outcome measure : Ultrasonography score PD mode (0-36) Disease activityscore DAS28-ESR (0-10) Disease activity score DAS28-CRP (0-10) Disease activity score SDAI (0-86) Disease activity score CDAI (0-76)
august 2015-april 2016
Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI).
Time Frame: august 2015-april 2016
Composit outcome measure : Ultrasonography score PD mode (0-36) Disease activityscore DAS28-ESR (0-10) Disease activity score DAS28-CRP (0-10) Disease activity score SDAI (0-86) Disease activity score CDAI (0-76)
august 2015-april 2016

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Philippe Gaudin, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.258
  • DR-2015-072 (Other Identifier: CNIL)

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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