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Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis

Monocentric Cross-sectional Study Assessing the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04325724
Acronym
EchoPRO
Enrollment
100
Registered
2020-03-30
Start date
2020-04-30
Completion date
2020-04-30
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

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.

Interventions

OTHERGeneral evaluation

Demographic characteristic, psoriasis duration, disease duration, treatments

treatment and evaluation

OTHERRheumatological evaluation

joints, enthesis, tendons, and other ultrasound abnormalities

OTHERpara clinical data

biological data, medical imaging data

Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

ultrasound evaluation will be on masking from clinical evaluation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis1 dayThe study of patient global assessment will permit to understand the impact of inflammation and external structural damage measured by ultrasound in patients with psoriatic arthritis (newly diagnosed or with confirmed diagnosis). At enrollment visit (only visit) of patient PGA will be assessed with a digital scale from 0 to 10

Secondary

MeasureTime frameDescription
Evaluation of the impact of inflammation and external structural damage measured by ultrasound1 dayEvaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: PGA joint damage activity and cutaneous damage will be measure with a digital scale

Contacts

Primary ContactMaria-Antonietta D'AGOSTINO, PhD
maria-antonietta.dagostino@aphp.fr+331 49 09 56 74

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026