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

NCT04857476 | Terminated

• 1 other identifier: 2021RHE115
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• PEST Scores

  To identify whether patients who have higher PEST scores are more likely to have features of psoriatic arthritis on ultrasound

  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

  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

  2 years

Study Arms (1)

skin psoriasis participants

OTHER

Single arm study

Diagnostic Test: Ultrasound scan

Interventions

Ultrasound scan DIAGNOSTIC_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

skin psoriasis participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Psoriasis by a dermatologist
• Aged 18 or more
• Reasonable fluency of spoken English

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

George Hirsch

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• George Hirsch

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: June 22, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)