Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease ActivityEVER-1NCT02930187
Ultrasound Evaluation of Remission in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Rheumatoid Arthritis in Routine Care
Who may be able to join
- 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
Who cannot join
- Patient participating to a clinical trial about rheumatoid arthritis treatment
- Patient under administrative supervision
About this study
Official title: 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.
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).
- Keywords
- Rheumatoid arthritis, remission, ultrasound
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: august 2015-april 2016
Secondary outcomes (2)
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)
Measured: august 2015-april 2016
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)
Measured: august 2015-april 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease ActivityStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Gaudin, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930187
- Sponsor's protocol ID
- 38RC14.258
- Other IDs
- DR-2015-072
- Acronym
- EVER-1
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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 16142705Aletaha 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 17678828Ozgocmen 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 18364651Balsa 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 20047979Saleem 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Disease Activity and Ultrasound Scoring (Naredo-12) in Patients With Rheumatoid Arthritis With Clinical Remission in Daily Practice.
- ClinicalTrials.gov ID
- NCT02930187
- Acronym / sponsor ID
- EVER-1 / 38RC14.258
- Keywords
- Rheumatoid arthritis, remission, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatoid Arthritis in Routine Care
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient participating to a clinical trial about rheumatoid arthritis treatment
- Patient under administrative supervision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI).
Time frame: august 2015-april 2016
Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI).
Time frame: august 2015-april 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 16142705Aletaha 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.
- Background: PubMed 17678828Aletaha 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.
- Background: PubMed 18364651Ozgocmen 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.
- Background: PubMed 20047979Balsa 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.
- Background: PubMed 21242236Saleem 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gaudin, Pr principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI) (time frame: august 2015-april 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930187, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.