PsA Patients Fulfilling CASPAR Criteria in RemissionPARURENCT03396679
Disparity Between Ultrasound- and Clinical Findings in Psoriatic Arthritis in Remission
An observational study of PsA Patients Fulfilling CASPAR Criteria in Remission, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Comparison of the proportion of Psoriatic arthritis patients in ultrasound remission (i.e. no power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether patient and physician's global assessment of disease activity are in agreement or in disagreement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PsA Patients Fulfilling CASPAR Criteria in Remission
- What is being tested?
- Ultrasound examination
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 29 Jun 2018
- Phase
- Observational
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: PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment
Who may be able to join
- PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment
Who cannot join
- patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?
Comparison of the proportion of Psoriatic arthritis patients in ultrasound remission (i.e. no power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether patient and physician's global assessment of disease activity are in agreement or in disagreement.
Read the detailed description
Current data indicate limited correlations between Ultrasound- and clinical findings of inflammation (synovitis, tenosynovitis, dactylitis, enthesitis) in psoriatic arthritis (PsA). This can could be in relation with subjective parameters included in composite clinical scores, such as patient's global assessment of disease activity. Indeed, there is often a disagreement between patient's and evaluator's global assessments of disease activity in psoriatic arthritisPsA. This can reduce the chance to obtain clinical remission, as defined by such composite clinical scores.
Does residual clinical activity assessed by the patient (and not by the evaluator) reflect objective inflammation assessed by ultrasound, or is it in relation with other factors such as fatigue or depression?
Objectives:
Primary end point:
In PsA patients deemed to be in remission according to their assessing consultant rheumatologist (i.e. low physician's global assessment of disease activity), to compare the proportion of patients with persistant persistent ultrasound findings of inflammation (i.e. at least one power Doppler synovitis, tenosynovitis, dactylitis or, enthesitis, "= PD>0") depending on whether patient and physician's global assessments of disease activity are in agreement or in disagreement (disagreement between patient and physician's global assessments defined by a difference on a VAS ≥ 30/100).
Secondary end points :
- Proportion of patients in clinical remission or low disease activity according to different clinical composite scores (DAS28-CRP, SDAI, DAPSA, et MDA) and proportion of patients in ultrasound remission or minimal ultrasound disease activity (defined as a PD-score=0 and a PD-score≤1 respectively), in this population.
- Comparison of rates of clinical remission and ultrasound remission in patients considered or not in remission according to DAPSA criteria
- Correlation between different composite clinical scores (DAS28-CRP, SDAI, DAPSA, MDA) and ultrasound findings (global power Doppler ultrasound sum score combining synovitis, tenosynovitis, enthesitis, then power Doppler ultrasound score for synovitis, tenosynovitis, enthesitis separately) in this population
- Correlation between different Patient Reported Outcomes (PROs such as HAQ, PsAID, DLQI) and ultrasound findings (global power Doppler ultrasound sum score combining synovitis, tenosynovitis, enthesitis, then power Doppler ultrasound score for synovitis, tenosynovitis, enthesitis separately) in this population
- Evaluation of factors associated with ultrasound remission (PD=0) and with minimal ultrasound disease activity (PD≤1)
- Evaluation of factors associated with a disagreement between patient and physician's global assessment of disease activity (patient global assessment on a VAS - physician's global assessment on a VAS ≥ 30/100).
Study design: prospective transversal observational study Inclusion criteria: PsA patients fulfilling CASPAR criteria in remission as determined by physician Exclusion criteria: patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients Outcome measure : Comparison of the proportion of patients in ultrasound remission (i.e. no power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether patient and physician's global assessments of disease activity are in agreement or in disagreement
- Being tested
- Ultrasound examination
- Keywords
- Psoriatic arthritis, remission, ultrasound
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Evaluation of the Psoriatic Arthritis remission according to patient and physician's global assessment of disease activity are in agreement (CASPAR criteria agreement) or in disagreement (CASPAR criteria disagreement)
| Study group | Role | What they receive |
|---|---|---|
| CASPAR criteria agreement | PsA patients fulfilling CASPAR criteria in remission as determined by physician with patient and physician's global assessment of disease activity in agreement compare to Ultrasound examination Receives: Other: Ultrasound examination | |
| CASPAR criteria disagreement | PsA patients fulfilling CASPAR criteria in remission as determined by physician with patient and physician's global assessment of disease activity in disagreement compare to Ultrasound examination Receives: Other: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Psoriasic arthritis remission
In PsA patients deemed to be in remission according to their assessing consultant rheumatologist (i.e. low physician's global assessment of disease activity), to compare the proportion of patients with persistant ultrasound findings of inflammation by Ultrasound examination (i.e. at least one power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, = PD>0) depending on whether patient and physician's global assessments of disease activity are in agreement or in disagreement.
Measured: 6 months
Secondary outcomes (14)
Comparison of proportion of patients in clinical remission to proportion of patients in ultrasound remission (or minimal ultrasound disease activity)
Proportion of patients in clinical remission or low disease activity according to different clinical composite scores (DAS28-CRP, SDAI, DAPSA, et MDA) and proportion of patients in ultrasound remission or minimal ultrasound disease activity (defined as a PD-score=0 and a PD-score≤1 respectively), in this population.
Measured: 6 months
Comparison of clinical remission and ultrasound remission according to DAPSA criteria
Comparison of rates of clinical remission and ultrasound remission in patients considered or not in remission according to DAPSA criteria
Measured: 6 months
Correlation between different composite clinical scores and ultrasound findings
Correlation between different composite clinical scores (Disease Activity Score 28-CRP (DAS28-CRP) in this population
Measured: 6 months
Correlation between different composite clinical scores and ultrasound findings
Correlation of Simplified Disease Activity Index (SDAI ; Score 0 (remission) to 26 (high activity)) in this population
Measured: 6 months
Correlation between different composite clinical scores and ultrasound findings
Correlation of Disease Activity Index for Psoriatic Arthritis (DAPSA ; Score 0 (remission) to 28 (high activity)) in this population
Measured: 6 months
Correlation between different composite clinical scores and ultrasound findings
Correlation of Minimal Disease Activity (MDA ; Score 5/7)) in this population
Measured: 6 months
Correlation between different composite clinical scores and ultrasound findings
Correlation of ultrasound findings (global power Doppler ultrasound sum score combining synovitis, tenosynovitis, enthesitis, then power Doppler ultrasound score for synovitis, tenosynovitis, enthesitis separately) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of PROs such as Health Assessment Questionnaire (HAQ) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of Psoriatic Arthritis Impact of Disease (PsAID) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of Dermatology Life Quality Index (DLQI) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of Pain Catastrophizing Scale (PCS) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of Fibromyalgia Rapid Screening Tool (FIRST) in this population
Measured: 6 months
Correlation between different Patient Reported Outcomes and ultrasound findings
Correlation of ultrasound findings (global power Doppler ultrasound sum score combining synovitis, tenosynovitis, enthesitis, then power Doppler ultrasound score for synovitis, tenosynovitis, enthesitis separately) in this population
Measured: 6 months
Evaluation of factors associated with a disagreement between patient and physician's global assessment of disease activity
Evaluation of factors associated with a disagreement between patient and physician's global assessment of disease activity (patient global assessment on a VAS - physician's global assessment on a VAS ≥ 30/100).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start2 Nov 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsA Patients Fulfilling CASPAR Criteria in RemissionStudies of the same condition, open and under way.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël MOUTERDE, MD, Principal investigator, Montpellier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396679
- Sponsor's protocol ID
- 9855
- Acronym
- PARURE
- Status last verified
- May 2019
- First submitted
- 13 Oct 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No