Back to resultsEvaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis (EchoPRO)
Primary Purpose
Psoriatic Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
General evaluation
Dermatological evaluation
Rheumatological evaluation
para clinical data
Patient reported outcomes (PROs)
Sponsored by
About this trial
This is an interventional prevention trial for Psoriatic Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Beginner psoriatic arthritis patients
Confirmed psoriatic arthritis patients
Rheumatoid arthritis or Digital osteoarthritis patients
Skin psoriasis patients without any articular symptoms
Arm 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
Every patients with psoriatic arthritis followed in rheumatologic department
Followed in rheumatologic department
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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)
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
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
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
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
Full Information
NCT ID
NCT04325724
First Posted
February 17, 2020
Last Updated
April 2, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04325724
Brief Title
Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
ultrasound evaluation will be on masking from clinical evaluation
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beginner psoriatic arthritis patients
Arm Type
Other
Arm 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
Arm Title
Confirmed psoriatic arthritis patients
Arm Type
Other
Arm Description
Every patients with psoriatic arthritis followed in rheumatologic department
Arm Title
Rheumatoid arthritis or Digital osteoarthritis patients
Arm Type
Other
Arm Description
Followed in rheumatologic department
Arm Title
Skin psoriasis patients without any articular symptoms
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
General evaluation
Intervention Description
Demographic characteristic, psoriasis duration, disease duration, treatments
Intervention Type
Other
Intervention Name(s)
Dermatological evaluation
Intervention Description
treatment and evaluation
Intervention Type
Other
Intervention Name(s)
Rheumatological evaluation
Intervention Description
joints, enthesis, tendons, and other ultrasound abnormalities
Intervention Type
Other
Intervention Name(s)
para clinical data
Intervention Description
biological data, medical imaging data
Intervention Type
Other
Intervention Name(s)
Patient reported outcomes (PROs)
Intervention Description
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
Primary Outcome Measure Information:
Title
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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)
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
Title
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria-Antonietta D'AGOSTINO, PhD
Phone
+331 49 09 56 74
Email
maria-antonietta.dagostino@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Antonietta D'AGOSTINO, PhD
Organizational Affiliation
Rheumatology Department, Ambroise Paré Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
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