Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
EchoPRO
Monocentric Cross-sectional Study Assessing the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
2 other identifiers
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 6, 2020
February 1, 2020
Same day
February 17, 2020
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
The 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
1 day
Secondary Outcomes (7)
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
1 day
- +2 more secondary outcomes
Study Arms (4)
Beginner psoriatic arthritis patients
OTHEREvery patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis
Confirmed psoriatic arthritis patients
OTHEREvery patients with psoriatic arthritis followed in rheumatologic department
Rheumatoid arthritis or Digital osteoarthritis patients
OTHERFollowed in rheumatologic department
Skin psoriasis patients without any articular symptoms
OTHERInterventions
Demographic characteristic, psoriasis duration, disease duration, treatments
treatment and evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
biological data, medical imaging data
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria-Antonietta D'AGOSTINO, PhD
Rheumatology Department, Ambroise Paré Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- ultrasound evaluation will be on masking from clinical evaluation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2020
First Posted
March 30, 2020
Study Start
April 1, 2020
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
April 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share