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Disparity Between Ultrasound- and Clinical Findings in Psoriatic Arthritis in Remission (PARURE)

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ClinicalTrials.gov Identifier: NCT03396679
Recruitment Status : Completed
First Posted : January 11, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment
PsA Patients Fulfilling CASPAR Criteria in Remission Other: Ultrasound examination

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


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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018


Group/Cohort Intervention/treatment
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
Other: Ultrasound examination
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)

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
Other: Ultrasound examination
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 Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396679


Locations
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France
CHU Lapeyronie
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Gaël MOUTERDE, MD Montpellier Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03396679     History of Changes
Other Study ID Numbers: 9855
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Psoriatic arthritis
remission
ultrasound
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases