PsA Patients Fulfilling CASPAR Criteria in Remission Clinical Trial
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.
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
;