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

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.

Study Overview

• Status: Unknown
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Other: General evaluation; Other: Dermatological evaluation; Other: Rheumatological evaluation; Other: para clinical data; Other: Patient reported outcomes (PROs)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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	Other: General evaluation; Demographic characteristic, psoriasis duration, disease duration, treatments; Other: Dermatological evaluation; treatment and evaluation; Other: Rheumatological evaluation; joints, enthesis, tendons, and other ultrasound abnormalities; Other: para clinical data; biological data, medical imaging data; Other: Patient reported outcomes (PROs); Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
OTHER: Confirmed psoriatic arthritis patients; Every patients with psoriatic arthritis followed in rheumatologic department	Other: General evaluation; Demographic characteristic, psoriasis duration, disease duration, treatments; Other: Dermatological evaluation; treatment and evaluation; Other: Rheumatological evaluation; joints, enthesis, tendons, and other ultrasound abnormalities; Other: para clinical data; biological data, medical imaging data; Other: Patient reported outcomes (PROs); Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
OTHER: Rheumatoid arthritis or Digital osteoarthritis patients; Followed in rheumatologic department	Other: General evaluation; Demographic characteristic, psoriasis duration, disease duration, treatments; Other: Rheumatological evaluation; joints, enthesis, tendons, and other ultrasound abnormalities; Other: para clinical data; biological data, medical imaging data; Other: Patient reported outcomes (PROs); Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
OTHER: Skin psoriasis patients without any articular symptoms	Other: General evaluation; Demographic characteristic, psoriasis duration, disease duration, treatments; Other: Dermatological evaluation; treatment and evaluation; Other: Rheumatological evaluation; joints, enthesis, tendons, and other ultrasound abnormalities; Other: para clinical data; biological data, medical imaging data; Other: Patient reported outcomes (PROs); Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Maria-Antonietta D'AGOSTINO, PhD, Rheumatology Department, Ambroise Paré Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Dermatologic Agents
• Other Study ID Numbers: APHP 190620; 2019-A01839-48 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No