Skip to main content
OpenTrials
Completed

NCT Number: NCT03396679

Disparity Between Ultrasound- and Clinical Findings in Psoriatic Arthritis 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment

Exclusion criteria

  • patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients

Treatment and study plan

Ultrasound examination

Other

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)

Primary outcomes

  1. Evaluation of Psoriasic arthritis remission

    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.

Secondary outcomes

  1. Comparison of proportion of patients in clinical remission to proportion of patients in ultrasound remission (or minimal ultrasound disease activity)

    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.

  2. Comparison of clinical remission and ultrasound remission according to DAPSA criteria

    Time frame: 6 months

    Comparison of rates of clinical remission and ultrasound remission in patients considered or not in remission according to DAPSA criteria

  3. Correlation between different composite clinical scores and ultrasound findings

    Time frame: 6 months

    Correlation between different composite clinical scores (Disease Activity Score 28-CRP (DAS28-CRP) in this population

  4. Correlation between different composite clinical scores and ultrasound findings

    Time frame: 6 months

    Correlation of Simplified Disease Activity Index (SDAI ; Score 0 (remission) to 26 (high activity)) in this population

  5. Correlation between different composite clinical scores and ultrasound findings

    Time frame: 6 months

    Correlation of Disease Activity Index for Psoriatic Arthritis (DAPSA ; Score 0 (remission) to 28 (high activity)) in this population

  6. Correlation between different composite clinical scores and ultrasound findings

    Time frame: 6 months

    Correlation of Minimal Disease Activity (MDA ; Score 5/7)) in this population

  7. Correlation between different composite clinical scores and ultrasound findings

    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

  8. Correlation between different Patient Reported Outcomes and ultrasound findings

    Time frame: 6 months

    Correlation of PROs such as Health Assessment Questionnaire (HAQ) in this population

  9. Correlation between different Patient Reported Outcomes and ultrasound findings

    Time frame: 6 months

    Correlation of Psoriatic Arthritis Impact of Disease (PsAID) in this population

  10. Correlation between different Patient Reported Outcomes and ultrasound findings

    Time frame: 6 months

    Correlation of Dermatology Life Quality Index (DLQI) in this population

  11. Correlation between different Patient Reported Outcomes and ultrasound findings

    Time frame: 6 months

    Correlation of Pain Catastrophizing Scale (PCS) in this population

  12. Correlation between different Patient Reported Outcomes and ultrasound findings

    Time frame: 6 months

    Correlation of Fibromyalgia Rapid Screening Tool (FIRST) in this population

  13. Correlation between different Patient Reported Outcomes and ultrasound findings

    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

  14. Evaluation of factors associated with a disagreement between patient and physician's global assessment of disease activity

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?

Acronym: PARURE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2018
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.