Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
NCT ID: NCT04325724
Last Updated: 2020-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-04-30
2020-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Beginner psoriatic arthritis patients
Every patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis
General evaluation
Demographic characteristic, psoriasis duration, disease duration, treatments
Dermatological evaluation
treatment and evaluation
Rheumatological evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical data
biological data, medical imaging data
Patient reported outcomes (PROs)
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Confirmed psoriatic arthritis patients
Every patients with psoriatic arthritis followed in rheumatologic department
General evaluation
Demographic characteristic, psoriasis duration, disease duration, treatments
Dermatological evaluation
treatment and evaluation
Rheumatological evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical data
biological data, medical imaging data
Patient reported outcomes (PROs)
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Rheumatoid arthritis or Digital osteoarthritis patients
Followed in rheumatologic department
General evaluation
Demographic characteristic, psoriasis duration, disease duration, treatments
Rheumatological evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical data
biological data, medical imaging data
Patient reported outcomes (PROs)
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Skin psoriasis patients without any articular symptoms
General evaluation
Demographic characteristic, psoriasis duration, disease duration, treatments
Dermatological evaluation
treatment and evaluation
Rheumatological evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical data
biological data, medical imaging data
Patient reported outcomes (PROs)
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Interventions
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General evaluation
Demographic characteristic, psoriasis duration, disease duration, treatments
Dermatological evaluation
treatment and evaluation
Rheumatological evaluation
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical data
biological data, medical imaging data
Patient reported outcomes (PROs)
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Maria-Antonietta D'AGOSTINO, PhD
Role: PRINCIPAL_INVESTIGATOR
Rheumatology Department, Ambroise Paré Hospital
Central Contacts
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Other Identifiers
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2019-A01839-48
Identifier Type: OTHER
Identifier Source: secondary_id
APHP 190620
Identifier Type: -
Identifier Source: org_study_id
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