EnthesitisNCT04209894
Detection of Subclinical Enthesitis by Ultrasonography
An observational study of Enthesitis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Detection of subclinical enthesitis by ultrasonography Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enthesitis
- What is being tested?
- Ultrasound
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 15 Mar 2023
- 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: Both patients with psoriasis and healthy controls.
Who may be able to join
- Age≥18years
- Patients with psoriasis without musculoskeletal symptoms
- Healthy controls
- No joint involvement and no clinical symptoms and signs of enthesitis and synovitis
Who cannot join
- Have history of gout or arthritis or peripheral neurological disease of lower extremity.
- Have history of trauma and intensive sport activity in last 2 weeks.
- Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, 34758
About this study
Official title: Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients With Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year
Detection of subclinical enthesitis by ultrasonography
Read the detailed description
A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.
- Conditions
- Enthesitis
- Being tested
- Ultrasound
- Keywords
- subclinical enthesitis, psoriasis, ultrasound, psoriatic arthritis
- 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.
UltrasoundDiagnostic test
Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Receives: Diagnostic Test: Ultrasound | |
| Control | They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year
Incidence of subclinical enthesitis,To investigate the incidence of subclinical enthesitis in patients with psoriasis
Measured: 1 year.
Secondary outcomes (1)
Number of participants with Risk factors of subclinical enthesitis
To find out predictor factors of subclinical enthesitis in patients with psoriasis. To assess increase in enthesis area and PsA incidence, and show a possible relationship with baseline findings in a prospective 1-year follow-up of patients with PsO.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start15 Sep 2021
- Primary completion15 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnthesitisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Duygu Silte Karamanlioglu, MD, Principal investigator, Fatih Sultan Mehmet Training and Research HospitalFeyza Unlu Ozkan, Prof., Study chair, Fatih Sultan Mehmet Training and Research HospitalEylem Ceren Arikan, MD, Study chair, Fatih Sultan Mehmet Training and Research HospitalBetül Zehra Pirdal, MD, Study chair, Istanbul Sultangazi District Health DirectorateGulcan Ozturk, MD, Study chair, Fatih Sultan Mehmet Training and Research HospitalIlknur Aktas, Prof, Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209894
- Sponsor's protocol ID
- karamanlioglu.duygu
- Status last verified
- Jun 2023
- First submitted
- 14 Dec 2019
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients With Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year
- ClinicalTrials.gov ID
- NCT04209894
- Acronym / sponsor ID
- karamanlioglu.duygu
- Conditions
- Enthesitis
- Keywords
- subclinical enthesitis, psoriasis, ultrasound, psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 24 Dec 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.
Detection of subclinical enthesitis by ultrasonography
Detailed description
A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Diagnostic Test: UltrasoundThey will undergo dermatological assessment and a blinded ultrasound (US) evaluation. |
| Control | – | Diagnostic Test: UltrasoundThey will also undergo dermatological assessment and a blinded ultrasound (US) evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both patients with psoriasis and healthy controls.
Key inclusion criteria (4 listed)
- Age≥18years
- Patients with psoriasis without musculoskeletal symptoms
- Healthy controls
- No joint involvement and no clinical symptoms and signs of enthesitis and synovitis
Key exclusion criteria (4 listed)
- Have history of gout or arthritis or peripheral neurological disease of lower extremity.
- Have history of trauma and intensive sport activity in last 2 weeks.
- Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
- Pregnant or breast-feeding
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 |
|---|---|---|
| UltrasoundEvaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities | Diagnostic test | Control, Psoriasis |
Primary outcome
Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year
Time frame: 1 year.
Incidence of subclinical enthesitis,To investigate the incidence of subclinical enthesitis in patients with psoriasis
1 secondary outcome
Number of participants with Risk factors of subclinical enthesitis
Time frame: 1 year
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 26 Jun 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.
Duygu Silte Karamanlioglu, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
Feyza Unlu Ozkan, Prof. study chair
Fatih Sultan Mehmet Training and Research Hospital
Eylem Ceren Arikan, MD study chair
Fatih Sultan Mehmet Training and Research 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 Enthesitis, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 26 Jun 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 Turkey (Türkiye). 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?
Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year (time frame: 1 year.). 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 26 Jun 2023.