Monocentric Cross-sectional Study Assessing the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
研究概览
简要总结
The perspective of the patient is defined by the patient reported outcomes (PROs). This is a main part of the care in psoriatic arthritis. However , PROs can be influenced by environmental parameters.
Ultrasound represents an objective instrument in the context of psoriatic rheumatism (RhPso) care because it measures inflammatory activity and structural damage at joint and periarticular level.
it is the first study to evaluate the role of inflammatory and structural ultrasound abnormalities as a cause of modification of the patient's perspective measured by PROs in patients with RhPso.
详细描述
It is an interventional study. Patients will be enrolled in the rheumatology department Of Ambroise Paré Hospital in collaboration with the dermatology departments of the hospital.
All patients with psoriatic arthritis, beginner or established, or patients with psoriasis suspecting the beginning of rheumatism who will consult or are already followed in those departments and give their approval for the study will undergo
- a clinical rheumatologic assessment (number of painful or swollen joints, enthesitic pain, inflammatory spinal pain)
- an ultrasound assessment (peripheral joints, tendon and enthesitic structures and nails).
Those assessment will be made the same day of their consult in one those departments. They will be asked to complete questionnaires (PROs) on the overall assessment of the disease, pain, quality of life, tiredness, physical limitation / disability and the impact of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
ultrasound evaluation will be on masking from clinical evaluation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders above 18 years old
- •Capable of adhering to the protocol
- •Consent given
- •Present one of those disease:
- •RhPso (confirmed diagnosis) according to The Classification for Psoriatic arthritis criteria (CASPAR)
- •Rheumatoid arthritis according to ACR/EULAR criteria (American College of Rheumatology/ European League Against Rheumatism)
- •Digital osteoarthritis according to american college of rheumatology (ACR) criteria
- •Cutaneous psoriasis
- •Having signed a consent form
- •Affiliated to a regimen of health insurance
排除标准
- •Patient refusing the study
- •The association of two rheumatic diseases (for example: psoriatic arthritis and gout, rheumatoid arthritis and arthritis etc)
- •The association of another chronic pathology likely to lead to joint manifestations (systemic diseases, bowel chronic inflammatory diseases, overload diseases, ...)
- •Patient under trusteeship or protection of vulnerable adults
- •Pregnant or nursing women
结局指标
主要结局
Evaluation of patient global assessment (PGA) in patients with Psoriatic Arthritis
时间窗: 1 day
The study of patient global assessment will permit to understand the impact of inflammation and external structural damage measured by ultrasound in patients with psoriatic arthritis (newly diagnosed or with confirmed diagnosis). At enrollment visit (only visit) of patient PGA will be assessed with a digital scale from 0 to 10
次要结局
- Evaluation of the impact of inflammation and external structural damage measured by ultrasound(1 day)