search
Back to results

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

Primary Purpose

Psoriatic Arthritis

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound scan
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • George Hirsch

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

skin psoriasis participants

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2021
Last Updated
November 16, 2022
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04857476
Brief Title
Do Patients With Skin Psoriasis Have Sub-clinical Features of Active Psoriatic Arthritis on Musculoskeletal UltraSound?
Acronym
PsACT-US
Official Title
Do Patients With Skin PSoriasis Have Sub-clinical Features of ACTive Psoriatic Arthritis on Musculoskeletal UltraSound?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
skin psoriasis participants
Arm Type
Other
Arm Description
Single arm study
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound scan
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
Description
proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound
Time Frame
3 years
Title
Risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound
Description
Are there any particular risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound?
Time Frame
3 years
Title
PEST Scores
Description
To identify whether patients who have higher PEST scores are more likely to have features of psoriatic arthritis on ultrasound
Time Frame
3 years
Title
PEST score element
Description
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
Time Frame
3 years
Title
High PEST score with normal ultrasound scan
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hirsch
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Hirsch
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs