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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
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.

France1 site
  • CHU Lapeyronie

    Montpellier, 34000

Other trials in France

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 groups in NCT03396679
Study groupRoleWhat they receive
CASPAR criteria agreementPsA 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 disagreementPsA 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Correlation between different composite clinical scores and ultrasound findings

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

    Measured: 6 months

  7. 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

  8. Correlation between different Patient Reported Outcomes and ultrasound findings

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

    Measured: 6 months

  9. Correlation between different Patient Reported Outcomes and ultrasound findings

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

    Measured: 6 months

  10. Correlation between different Patient Reported Outcomes and ultrasound findings

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

    Measured: 6 months

  11. Correlation between different Patient Reported Outcomes and ultrasound findings

    Correlation of Pain Catastrophizing Scale (PCS) in this population

    Measured: 6 months

  12. Correlation between different Patient Reported Outcomes and ultrasound findings

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

    Measured: 6 months

  13. 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

  14. 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.

  1. First posted11 Jan 2018
  2. Study start2 Nov 2017
  3. Primary completion29 Jun 2018
  4. Study completion29 Jun 2018

Resources

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)
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

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