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

Psoriatic Arthritis Clinical Trial

— EchoPRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04325724
• Other study ID #: APHP 190620
• Secondary ID: 2019-A01839-48
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: April 2020

Study information

• Verified date: February 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maria-Antonietta D'AGOSTINO, PhD
• Phone: +331 49 09 56 74
• Email: maria-antonietta.dagostino[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate 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	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: Pain will be assessed with a digital scale	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: Physical limitation/ disability will be assessed with the health assessment questionnaire (HAQ)	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: Quality of life will be assessed with a short form-36 (SF-36) questionnaire	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: Disease effect will be assessed with psoriatic arthritis impact of disease (PsAID) 12 questionnaire	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Evaluate the impact of inflammation and external structural damage measured by ultrasound to explain the others PROs: Fatigue will be assessed with a digital scale	1 day
Secondary	Evaluation of the impact of inflammation and external structural damage measured by ultrasound	Compare the results( prevalence of ultrasound irregularity, PROs, and factor which explain PROs) to people who suffer from psoriatic, without damage, without sign of joints damages or rheumatoid arthritis (RA) or digital osteoarthritis.; Ultrasound damages: Synovitis, tenosynovitis, enthesitis, dactylitis, erosions, periosteal appositions ( enthesophytes, osteophyte and bony cortical irregularity) will be defined according to established by outcome measures in rheumatology (OMERACT) definitions and rating according to scores established by OMERACT	1 day