CHU Lapeyronie
Montpellier, 34000, France
NCT Number: NCT03396679
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.
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Notify Me18 year and older
All sexes
Observational
Montpellier, 34000, France
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 :
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Comparison of rates of clinical remission and ultrasound remission in patients considered or not in remission according to DAPSA criteria
Time frame: 6 months
Correlation between different composite clinical scores (Disease Activity Score 28-CRP (DAS28-CRP) in this population
Time frame: 6 months
Correlation of Simplified Disease Activity Index (SDAI ; Score 0 (remission) to 26 (high activity)) in this population
Time frame: 6 months
Correlation of Disease Activity Index for Psoriatic Arthritis (DAPSA ; Score 0 (remission) to 28 (high activity)) in this population
Time frame: 6 months
Correlation of Minimal Disease Activity (MDA ; Score 5/7)) in this population
Time frame: 6 months
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
Time frame: 6 months
Correlation of PROs such as Health Assessment Questionnaire (HAQ) in this population
Time frame: 6 months
Correlation of Psoriatic Arthritis Impact of Disease (PsAID) in this population
Time frame: 6 months
Correlation of Dermatology Life Quality Index (DLQI) in this population
Time frame: 6 months
Correlation of Pain Catastrophizing Scale (PCS) in this population
Time frame: 6 months
Correlation of Fibromyalgia Rapid Screening Tool (FIRST) in this population
Time frame: 6 months
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
Time frame: 6 months
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).
University Hospital, Montpellier
Other
Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?
Acronym: PARURE
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