PsA Patients Fulfilling CASPAR Criteria in Remission Clinical Trial
— PARUREOfficial title:
Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?
| NCT number | NCT03396679 |
| Other study ID # | 9855 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2, 2017 |
| Est. completion date | June 29, 2018 |
| Verified date | May 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | June 29, 2018 |
| Est. primary completion date | June 29, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Lapeyronie | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | |
| Secondary | 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. | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | Correlation between different composite clinical scores and ultrasound findings | Correlation of Minimal Disease Activity (MDA ; Score 5/7)) in this population | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | Correlation between different Patient Reported Outcomes and ultrasound findings | Correlation of PROs such as Health Assessment Questionnaire (HAQ) in this population | 6 months | |
| Secondary | Correlation between different Patient Reported Outcomes and ultrasound findings | Correlation of Psoriatic Arthritis Impact of Disease (PsAID) in this population | 6 months | |
| Secondary | Correlation between different Patient Reported Outcomes and ultrasound findings | Correlation of Dermatology Life Quality Index (DLQI) in this population | 6 months | |
| Secondary | Correlation between different Patient Reported Outcomes and ultrasound findings | Correlation of Pain Catastrophizing Scale (PCS) in this population | 6 months | |
| Secondary | Correlation between different Patient Reported Outcomes and ultrasound findings | Correlation of Fibromyalgia Rapid Screening Tool (FIRST) in this population | 6 months | |
| Secondary | 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 | 6 months | |
| Secondary | 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). | 6 months |