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CompletedNCT02930187EVER-1Updated Oct 12, 2016

Ultrasound Evaluation of Remission in Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity, sponsored by University Hospital, Grenoble. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
225
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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).

02

Conditions studied

  • Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity

Keywords

  • Rheumatoid arthritis, remission, ultrasound
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In context

Arthritis, Rheumatoid

2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 225 is above the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 206 are open to participants now.

Browse University Hospital, Grenoble studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Rheumatoid Arthritis in Routine Care

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient participating to a clinical trial about rheumatoid arthritis treatment
  • Patient under administrative supervision
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
225 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI)

    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)

    Time frame: august 2015-april 2016

Secondary outcomes

  1. Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI).

    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)

    Time frame: august 2015-april 2016

  2. Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI).

    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)

    Time frame: august 2015-april 2016

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Aletaha D, Ward MM, Machold KP, Nell VP, Stamm T, Smolen JS. Remission and active disease in rheumatoid arthritis: defining criteria for disease activity states. Arthritis Rheum. 2005 Sep;52(9):2625-36. doi: 10.1002/art.21235. PubMed 16142705 ↗
  • Aletaha D, Smolen JS. The Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) to monitor patients in standard clinical care. Best Pract Res Clin Rheumatol. 2007 Aug;21(4):663-75. doi: 10.1016/j.berh.2007.02.004. PubMed 17678828 ↗
  • Ozgocmen S, Ozdemir H, Kiris A, Bozgeyik Z, Ardicoglu O. Clinical evaluation and power Doppler sonography in rheumatoid arthritis: evidence for ongoing synovial inflammation in clinical remission. South Med J. 2008 Mar;101(3):240-5. doi: 10.1097/SMJ.0b013e318164e16a. PubMed 18364651 ↗
  • Balsa A, de Miguel E, Castillo C, Peiteado D, Martin-Mola E. Superiority of SDAI over DAS-28 in assessment of remission in rheumatoid arthritis patients using power Doppler ultrasonography as a gold standard. Rheumatology (Oxford). 2010 Apr;49(4):683-90. doi: 10.1093/rheumatology/kep442. Epub 2010 Jan 4. PubMed 20047979 ↗
  • Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Wakefield R, Karim Z, Quinn M, Hensor E, Conaghan PG, Emery P. Should imaging be a component of rheumatoid arthritis remission criteria? A comparison between traditional and modified composite remission scores and imaging assessments. Ann Rheum Dis. 2011 May;70(5):792-8. doi: 10.1136/ard.2010.134445. Epub 2011 Jan 17. PubMed 21242236 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2016
First posted
Oct 12, 2016
Start
Mar 2015
Primary completionActual
Apr 2016
CompletionActual
Apr 2016
Last update
Oct 12, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02930187
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Oct 12, 2016
Start date
Mar 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Oct 12, 2016

Study contacts

Philippe Gaudin, Pr
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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