Psoriatic ArthritisPsACT-USNCT04857476
Do Patients With Skin Psoriasis Have Sub-clinical Features of Active Psoriatic Arthritis on Musculoskeletal UltraSound?
A study testing Ultrasound scan in people with Psoriatic Arthritis, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Psoriatic Arthritis is an inflammatory condition that typically affects joints and soft tissues such as tendons. Poorly controlled or untreated psoriatic arthritis can lead to joint damage, disability and poor physical and mental wellbeing. 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?
- Ultrasound scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2021to 30 Jul 2021
- 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
- Diagnosis of Psoriasis by a dermatologist
- Aged 18 or more
- Reasonable fluency of spoken English
Who cannot join
- Existing diagnosis of Psoriatic arthritis
- Currently on biologics for treatment of their skin Psoriasis (as this would potentially treat and thereby diminish joint symptoms associated with PsA)
- Aged <18years old (the study focusses on an adult population)
- Currently in prison (would be unable to attend the study ultrasound scan)
- Unable to give written consent for a musculoskeletal ultrasound e.g. advanced dementia, learning difficulties (may be unable to appreciate the reason for the study and may be unable to tolerate sitting relatively still for an ultrasound scan for 60 minutes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Patients With Skin PSoriasis Have Sub-clinical Features of ACTive Psoriatic Arthritis on Musculoskeletal UltraSound?
Psoriatic Arthritis is an inflammatory condition that typically affects joints and soft tissues such as tendons. Poorly controlled or untreated psoriatic arthritis can lead to joint damage, disability and poor physical and mental wellbeing. Evidence suggests that early diagnosis and treatment of psoriatic arthritis can minimise adverse health outcomes.
Musculoskeletal ultrasound has become an extremely useful tool in aiding rheumatologists to diagnose inflammatory joint conditions particularly at an early stage in the course of a disease.
Read more
Psoriatic arthritis is known to affect up to 30% of patients with skin psoriasis. Therefore, national dermatology guidelines advise that patients with skin psoriasis should be asked about any joint symptoms at least every year.
This study investigates whether skin psoriasis patients who are not on biologic treatment are indeed being asked about any joint symptoms and we subsequently invite patients for a musculoskeletal ultrasound scan to see if they have features of early psoriatic arthritis on ultrasound. Those who do are then invited for a thorough rheumatology clinical assessment.
- Conditions
- Psoriatic Arthritis
- Being tested
- Ultrasound scan
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanDiagnostic test
Psoriasis epidemiology screening tool (PEST) score for completion Brief questionnaire about current psoriasis symptoms, current treatment and if any features associated with psoriatic arthritis.
One-off musculo-skeletal ultrasound Questionnaire at 2 years
| Study group | Role | What they receive |
|---|---|---|
| skin psoriasis participants | Other | Single arm study Receives: Diagnostic Test: Ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
Measured: 3 years
Risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound
Are there any particular risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound?
Measured: 3 years
PEST Scores
To identify whether patients who have higher PEST scores are more likely to have features of psoriatic arthritis on ultrasound
Measured: 3 years
PEST score element
Which element of a PEST score, if reported by a patient, is most likely to be associated with features of psoriatic arthritis on musculoskeletal ultrasound
Measured: 3 years
High PEST score with normal ultrasound scan
Are patients with a high PEST score and a normal initial musculoskeletal ultrasound scan more likely to be diagnosed with Psoriatic arthritis after 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start22 Jun 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: Due to work commitment and time constraints, the study had to finish early..
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- George Hirsch, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857476
- Sponsor's protocol ID
- 2021RHE115
- Acronym
- PsACT-US
- Status last verified
- Sep 2024
- First submitted
- 21 Apr 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients With Skin PSoriasis Have Sub-clinical Features of ACTive Psoriatic Arthritis on Musculoskeletal UltraSound?
- ClinicalTrials.gov ID
- NCT04857476
- Acronym / sponsor ID
- PsACT-US / 2021RHE115
- Conditions
- Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to work commitment and time constraints, the study had to finish early..
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 23 Apr 2021 (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.
Psoriatic Arthritis is an inflammatory condition that typically affects joints and soft tissues such as tendons. Poorly controlled or untreated psoriatic arthritis can lead to joint damage, disability and poor physical and mental wellbeing. Evidence suggests that early diagnosis and treatment of psoriatic arthritis can minimise adverse health outcomes.
Musculoskeletal ultrasound has become an extremely useful tool in aiding rheumatologists to diagnose inflammatory joint conditions particularly at an early stage in the course of a disease.
Psoriatic arthritis is known to affect up to 30% of patients with skin psoriasis. Therefore, national dermatology guidelines advise that patients with skin psoriasis should be asked about any joint symptoms at least every year.
This study investigates whether skin psoriasis patients who are not on biologic treatment are indeed being asked about any joint symptoms and we subsequently invite patients for a musculoskeletal ultrasound scan to see if they have features of early psoriatic arthritis on ultrasound. Those who do are then invited for a thorough rheumatology clinical assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin psoriasis participants | Other | Diagnostic Test: Ultrasound scanSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Psoriasis by a dermatologist
- Aged 18 or more
- Reasonable fluency of spoken English
Key exclusion criteria (5 listed)
- Existing diagnosis of Psoriatic arthritis
- Currently on biologics for treatment of their skin Psoriasis (as this would potentially treat and thereby diminish joint symptoms associated with PsA)
- Aged <18years old (the study focusses on an adult population)
- Currently in prison (would be unable to attend the study ultrasound scan)
- Unable to give written consent for a musculoskeletal ultrasound e.g. advanced dementia, learning difficulties (may be unable to appreciate the reason for the study and may be unable to tolerate sitting relatively still for an ultrasound scan for 60 minutes)
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 scanPsoriasis epidemiology screening tool (PEST) score for completion Brief questionnaire about current psoriasis symptoms, current treatment and if any features associated with psoriatic arthritis. One-off musculo-skeletal ultrasound Questionnaire at 2 years | Diagnostic test | skin psoriasis participants |
Primary outcome
Proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
Time frame: 3 years
proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
Risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound
Time frame: 3 years
Are there any particular risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound?
PEST Scores
Time frame: 3 years
To identify whether patients who have higher PEST scores are more likely to have features of psoriatic arthritis on ultrasound
PEST score element
Time frame: 3 years
Which element of a PEST score, if reported by a patient, is most likely to be associated with features of psoriatic arthritis on musculoskeletal ultrasound
High PEST score with normal ultrasound scan
Time frame: 2 years
Are patients with a high PEST score and a normal initial musculoskeletal ultrasound scan more likely to be diagnosed with Psoriatic arthritis after 2 years
Results and safety
The study was stopped early (reason given: Due to work commitment and time constraints, the study had to finish early..). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
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.
George Hirsch principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound scan in people with Psoriatic Arthritis, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 United Kingdom. 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 was stopped early (reason given: Due to work commitment and time constraints, the study had to finish early..). Results are not available in the source record.
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?
Proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound (time frame: 3 years). 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 19 Sep 2024.