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临床试验/NCT04857476
NCT04857476进行中(未招募)不适用

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

The Royal Wolverhampton Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
130
试验地点
2
主要终点
PEST Scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

PEST Scores

时间窗: 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

时间窗: 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

时间窗: 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

Proportion of patients with known skin psoriasis have features in keeping with psoriatic arthritis on musculoskeletal ultrasound

时间窗: 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

时间窗: 3 years

Are there any particular risk factors associated with those psoriasis patients who do have features of psoriatic arthritis on musculoskeletal ultrasound?

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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