PsoriasisEchoPsoNCT04074070
Prevalence of Sonographic Abnormalities of Joints and Entheses in Psoriasis Patients With or Without Musculoskeletal Complains
An observational study of Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objectives of this study are: to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms; to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ultrasound examination
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2020to 30 Sep 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients consulting the dermatology department of Ambroise Paré hospital for cutaneous psoriasis between September 2019 and December 2020.
Who may be able to join
- Age ≥ 18 years;
- Psoriasis diagnosed by a dermatologist;
- Able to participate in the study;
- Informed consent signed.
Who cannot join
- Chronic disease likely to cause musculoskeletal symptoms (connective tissue diseases, inflammatory bowel diseases, overload disorders, crystal related arthritis, septic arthritis...).
Trial locations and contacts
1 site in 1 country.
France1 site
Rheumatology Department, Ambroise Paré Hospital
Boulogne-Billancourt, 92100
About this study
Official title: Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains
The objectives of this study are:
- to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms;
- to compare them to healthy subjects or patients suffering from rheumatoid arthritis and osteoarthritis.
- Conditions
- Psoriasis
- Being tested
- Ultrasound examination
- Keywords
- psoriasis, psoriatic arthritis, ultrasound
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Ultrasound examination of joints, tendons and entheses.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis with and without musculoskeletal complains | psoriasis with and without musculoskeletal complains Receives: Other: Ultrasound examination | |
| Healthy individuals | Not described Receives: Other: Ultrasound examination | |
| Psoriatic arthritis | Not described Receives: Other: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
synovitis
Number and percentage, N (%) of patients with at least one synovitis.
Measured: through study completion, an average of 1 year
enthesitis
N (%) of patients with at least one ultrasound enthesitis.
Measured: through study completion, an average of 1 year
joint erosion
N (%) of patients with at least one joint erosion.
Measured: through study completion, an average of 1 year
osteophyte/ cortical irregularity
N (%) of patients with at least one osteophyte/ cortical irregularity.
Measured: through study completion, an average of 1 year
enthesophyte
N (%) of patients with at least one enthesophyte.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start18 Feb 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria-Antonietta D'Agostino, MD, PhD, Principal investigator, Rheumatology Department, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074070
- Sponsor's protocol ID
- APHP190683
- Other IDs
- 2018-A02781-54
- Acronym
- EchoPso
- Status last verified
- Mar 2023
- First submitted
- 19 Aug 2019
- Last updated
- 16 Mar 2023
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains
- ClinicalTrials.gov ID
- NCT04074070
- Acronym / sponsor ID
- EchoPso / APHP190683
- Conditions
- Psoriasis
- Keywords
- psoriasis, psoriatic arthritis, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Aug 2019 (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 objectives of this study are:
- to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms;
- to compare them to healthy subjects or patients suffering from rheumatoid arthritis and osteoarthritis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriasis with and without musculoskeletal complains | – | Other: Ultrasound examinationpsoriasis with and without musculoskeletal complains |
| Healthy individuals | – | Other: Ultrasound examination |
| Psoriatic arthritis | – | Other: Ultrasound examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients consulting the dermatology department of Ambroise Paré hospital for cutaneous psoriasis between September 2019 and December 2020.
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Psoriasis diagnosed by a dermatologist;
- Able to participate in the study;
- Informed consent signed.
Key exclusion criteria (1 listed)
- Chronic disease likely to cause musculoskeletal symptoms (connective tissue diseases, inflammatory bowel diseases, overload disorders, crystal related arthritis, septic arthritis...).
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 |
|---|---|---|
| Ultrasound examinationUltrasound examination of joints, tendons and entheses. | Other | Healthy individuals, Psoriasis with and without musculoskeletal complains, Psoriatic arthritis |
Primary outcome
synovitis
Time frame: through study completion, an average of 1 year
Number and percentage, N (%) of patients with at least one synovitis.
enthesitis
Time frame: through study completion, an average of 1 year
N (%) of patients with at least one ultrasound enthesitis.
joint erosion
Time frame: through study completion, an average of 1 year
N (%) of patients with at least one joint erosion.
osteophyte/ cortical irregularity
Time frame: through study completion, an average of 1 year
N (%) of patients with at least one osteophyte/ cortical irregularity.
enthesophyte
Time frame: through study completion, an average of 1 year
N (%) of patients with at least one enthesophyte.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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, MD, PhD principal investigator
Rheumatology Department, Ambroise Paré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
synovitis (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 16 Mar 2023.