Psoriatic ArthritisEchoPRONCT04325724
Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
A study testing General evaluation, Dermatological evaluation and Rheumatological evaluation in people with Psoriatic Arthritis, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- General evaluation, Dermatological evaluation and Rheumatological evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Digital osteoarthritis according to american college of rheumatology (ACR) criteria
- Cutaneous psoriasis
- Having signed a consent form
- Affiliated to a regimen of health insurance
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- General evaluation, Dermatological evaluation, Rheumatological evaluation, para clinical data, Patient reported outcomes (PROs)
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General evaluationOther
Demographic characteristic, psoriasis duration, disease duration, treatments
Dermatological evaluationOther
treatment and evaluation
Rheumatological evaluationOther
joints, enthesis, tendons, and other ultrasound abnormalities
para clinical dataOther
biological data, medical imaging data
Patient reported outcomes (PROs)Other
Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
| Study group | Role | What they receive |
|---|---|---|
| Beginner psoriatic arthritis patients | Other | Every patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis Receives: Other: General evaluation; Other: Dermatological evaluation; Other: Rheumatological evaluation; Other: para clinical data; Other: Patient reported outcomes (PROs) |
| Confirmed psoriatic arthritis patients | Other | Every patients with psoriatic arthritis followed in rheumatologic department Receives: Other: General evaluation; Other: Dermatological evaluation; Other: Rheumatological evaluation; Other: para clinical data; Other: Patient reported outcomes (PROs) |
| Rheumatoid arthritis or Digital osteoarthritis patients | Other | Followed in rheumatologic department Receives: Other: General evaluation; Other: Rheumatological evaluation; Other: para clinical data; Other: Patient reported outcomes (PROs) |
| Skin psoriasis patients without any articular symptoms | Other | Not described Receives: Other: General evaluation; Other: Dermatological evaluation; Other: Rheumatological evaluation; Other: para clinical data; Other: Patient reported outcomes (PROs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (7)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria-Antonietta D'AGOSTINO, PhD, Principal investigator, Rheumatology Department, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325724
- Sponsor's protocol ID
- APHP 190620
- Other IDs
- 2019-A01839-48
- Acronym
- EchoPRO
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Cross-sectional Study Assessing the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04325724
- Acronym / sponsor ID
- EchoPRO / APHP 190620
- Conditions
- Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beginner psoriatic arthritis patients | Other | Other: General evaluation, Other: Dermatological evaluation, Other: Rheumatological evaluation, Other: para clinical data, Other: Patient reported outcomes (PROs)Every patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis |
| Confirmed psoriatic arthritis patients | Other | Other: General evaluation, Other: Dermatological evaluation, Other: Rheumatological evaluation, Other: para clinical data, Other: Patient reported outcomes (PROs)Every patients with psoriatic arthritis followed in rheumatologic department |
| Rheumatoid arthritis or Digital osteoarthritis patients | Other | Other: General evaluation, Other: Rheumatological evaluation, Other: para clinical data, Other: Patient reported outcomes (PROs)Followed in rheumatologic department |
| Skin psoriasis patients without any articular symptoms | Other | Other: General evaluation, Other: Dermatological evaluation, Other: Rheumatological evaluation, Other: para clinical data, Other: Patient reported outcomes (PROs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General evaluationDemographic characteristic, psoriasis duration, disease duration, treatments | Other | Beginner psoriatic arthritis patients, Confirmed psoriatic arthritis patients, Rheumatoid arthritis or Digital osteoarthritis patients, Skin psoriasis patients without any articular symptoms |
| Dermatological evaluationtreatment and evaluation | Other | Beginner psoriatic arthritis patients, Confirmed psoriatic arthritis patients, Skin psoriasis patients without any articular symptoms |
| Rheumatological evaluationjoints, enthesis, tendons, and other ultrasound abnormalities | Other | Beginner psoriatic arthritis patients, Confirmed psoriatic arthritis patients, Rheumatoid arthritis or Digital osteoarthritis patients, Skin psoriasis patients without any articular symptoms |
| para clinical databiological data, medical imaging data | Other | Beginner psoriatic arthritis patients, Confirmed psoriatic arthritis patients, Rheumatoid arthritis or Digital osteoarthritis patients, Skin psoriasis patients without any articular symptoms |
| Patient reported outcomes (PROs)Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36 | Other | Beginner psoriatic arthritis patients, Confirmed psoriatic arthritis patients, Rheumatoid arthritis or Digital osteoarthritis patients, Skin psoriasis patients without any articular symptoms |
Primary outcome
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
Time frame: 1 day
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
7 secondary outcomes
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Evaluation of the impact of inflammation and external structural damage measured by ultrasound
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria-Antonietta D'AGOSTINO, PhD principal investigator
Rheumatology Department, Ambroise Paré Hospital
Questions about this trial
What is this clinical trial studying?
A study testing General evaluation, Dermatological evaluation and Rheumatological evaluation in people with Psoriatic Arthritis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria-Antonietta D'AGOSTINO, PhD (+331 49 09 56 74, maria-antonietta.dagostino@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.