Clinical trial NCT04325724: Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
Official title: Monocentric Cross-sectional Study Assessing the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriatic Arthritis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The perspective of the patient is defined by the patient reported outcomes (PROs). This is a main part of the care in psoriatic arthritis. However , PROs can be influenced by environmental parameters.

Ultrasound represents an objective instrument in the context of psoriatic rheumatism (RhPso) care because it measures inflammatory activity and structural damage at joint and periarticular level.

it is the first study to evaluate the role of inflammatory and structural ultrasound abnormalities as a cause of modification of the patient's perspective measured by PROs in patients with RhPso.

Detailed description: It is an interventional study. Patients will be enrolled in the rheumatology department Of Ambroise Paré Hospital in collaboration with the dermatology departments of the hospital.

All patients with psoriatic arthritis, beginner or established, or patients with psoriasis suspecting the beginning of rheumatism who will consult or are already followed in those departments and give their approval for the study will undergo

* a clinical rheumatologic assessment (number of painful or swollen joints, enthesitic pain, inflammatory spinal pain)
* an ultrasound assessment (peripheral joints, tendon and enthesitic structures and nails).

Those assessment will be made the same day of their consult in one those departments. They will be asked to complete questionnaires (PROs) on the overall assessment of the disease, pain, quality of life, tiredness, physical limitation / disability and the impact of the disease.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders above 18 years old
* Capable of adhering to the protocol
* Consent given
* Present one of those disease:
* RhPso (confirmed diagnosis) according to The Classification for Psoriatic arthritis criteria (CASPAR)
* Rheumatoid arthritis according to ACR/EULAR criteria (American College of Rheumatology/ European League Against Rheumatism)
* Digital osteoarthritis according to american college of rheumatology (ACR) criteria
* Cutaneous psoriasis
* Having signed a consent form
* Affiliated to a regimen of health insurance

Exclusion Criteria:

* Patient refusing the study
* The association of two rheumatic diseases (for example: psoriatic arthritis and gout, rheumatoid arthritis and arthritis etc)
* The association of another chronic pathology likely to lead to joint manifestations (systemic diseases, bowel chronic inflammatory diseases, overload diseases, ...)
* Patient under trusteeship or protection of vulnerable adults
* Pregnant or nursing women

Primary outcomes:
measure: Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
measure: Evaluation of the impact of inflammation and external structural damage measured by ultrasound
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Rheumatology Department, Ambroise Paré Hospital
name: Maria-Antonietta D'AGOSTINO, PhD
role: PRINCIPAL_INVESTIGATOR
References: