Ultrasound Evaluation of Remission in Rheumatoid Arthritis

Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity Clinical Trial

— EVER-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930187
• Other study ID #: 38RC14.258
• Secondary ID: DR-2015-072
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: October 7, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: French : Comission Nationale de l'Informatique et des Libertés
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

References & Publications (5)

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. — View 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. — View Citation

Balsa A, de Miguel E, Castillo C, Peiteado D, Martín-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	august 2015-april 2016	No
Secondary	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)	august 2015-april 2016	No
Secondary	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)	august 2015-april 2016	No