Do Patients With Skin Psoriasis Have Sub-clinical Features of Active Psoriatic Arthritis on Musculoskeletal UltraSound?

Psoriatic Arthritis Clinical Trial

— PsACT-US  

Official title:

Do Patients With Skin PSoriasis Have Sub-clinical Features of ACTive Psoriatic Arthritis on Musculoskeletal UltraSound?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04857476
• Other study ID #: 2021RHE115
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Psoriasis by a dermatologist

• Aged 18 or more

• Reasonable fluency of spoken English

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Intervention

Diagnostic Test:
• Ultrasound scan
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

Locations

Country	Name	City	State
United Kingdom	George Hirsch	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Primary	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?	3 years
Primary	PEST Scores	To identify whether patients who have higher PEST scores are more likely to have features of psoriatic arthritis on ultrasound	3 years
Primary	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	3 years
Primary	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	2 years