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

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Psoriatic Arthritis

Treatments

Other: Rheumatological evaluation
Other: General evaluation
Other: Patient reported outcomes (PROs)
Other: Dermatological evaluation
Other: para clinical data

Study type

Interventional

Funder types

Other

Identifiers

NCT04325724
APHP 190620
2019-A01839-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 4 patient groups

Beginner psoriatic arthritis patients
Other group
Description:
Every patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis
Treatment:
Other: para clinical data
Other: Patient reported outcomes (PROs)
Other: Rheumatological evaluation
Other: General evaluation
Other: Dermatological evaluation
Confirmed psoriatic arthritis patients
Other group
Description:
Every patients with psoriatic arthritis followed in rheumatologic department
Treatment:
Other: para clinical data
Other: Patient reported outcomes (PROs)
Other: Rheumatological evaluation
Other: General evaluation
Other: Dermatological evaluation
Rheumatoid arthritis or Digital osteoarthritis patients
Other group
Description:
Followed in rheumatologic department
Treatment:
Other: para clinical data
Other: Patient reported outcomes (PROs)
Other: Rheumatological evaluation
Other: General evaluation
Skin psoriasis patients without any articular symptoms
Other group
Treatment:
Other: para clinical data
Other: Patient reported outcomes (PROs)
Other: Rheumatological evaluation
Other: General evaluation
Other: Dermatological evaluation

Trial contacts and locations

0

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Central trial contact

Maria-Antonietta D'AGOSTINO, PhD

Data sourced from clinicaltrials.gov

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