Clinical trial NCT02930187: Ultrasound Evaluation of Remission in Rheumatoid Arthritis
Official title: Agreement Between Disease Activity and Ultrasound Scoring (Naredo-12) in Patients With Rheumatoid Arthritis With Clinical Remission in Daily Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity
Keywords: Rheumatoid arthritis, remission, ultrasound
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid Arthritis in Routine Care

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI)
timeFrame: august 2015-april 2016
Secondary outcomes:
measure: Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI).
timeFrame: august 2015-april 2016
measure: Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI).
timeFrame: august 2015-april 2016
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Philippe Gaudin, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.