An Observational Study Evaluating the Utility of Ultrasound Confirmed Enthesitis as a Prognostic Marker for Response to Biologic Therapy in Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The change in Madrid enthesitis ultrasound index (MASEI) score
研究概览
简要总结
The aim of this observational study will be to recruit 100 Psoriatic Arthritis (PsA) patients beginning on their biologic therapy and asses, both clinically and with the use of ultrasound (US), how enthesitis responds to biologic treatment.
The decision to start treatment with a biologic therapy will be made by the patients' usual clinical rheumatology team, as part of their standard clinical care. This is independent of the study. Patients in whom treatment with these drugs for their PsA has been recommended will then be invited to participate in this study.They will then be commenced on biologic therapy at doses in line with the Summary of Product characteristics (SPC) for the product and followed up in the hospital outpatient clinic.
Patients will have a full history taken and clinical exam performed prior to commencing on their prescribed biologic. The patient's history, Health Assessment Questionnaire scores and biobanking samples will be taken by the co-investigator. They will also calculate the patients tender and swollen joint score, dactylitis score, skin score, nail score and clinical enthesitis score.They will then have their tender entheseal points scanned as well as those as per the MASEI (Madrid Sonographic Enthesitis Index ) protocol by a single rheumatologist. The rheumatologist will be trained in ultrasound and will perform the scans blinded to this information both at initial consultation and at subsequent reviews.
The patient will then commence their biologic treatment as planned at a separate review as per usual practise with their clinical team.
Follow-up and final assessment at 4 months (±2 weeks) after starting biologic will include the clinical and ultrasound assessments as per the initial review and outlined in the schedule of assessments. They will also have a final blood sample taken at this point.
详细描述
Objective: This study will aim to clarify, in a cohort of active PsA patients, what is the prevalence of US confirmed enthesitis, what happens to these scores after biologic treatment, does this correlate with clinical scores and can enthesitis then serve as a prognostic tool in predicting response in patients receiving their biologic therapy.
Aims and objectives:
Primary outcome:
-The change in MASEI score at 4 months from baseline assessment.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The change in Madrid enthesitis ultrasound index (MASEI) score
时间窗: 4 months
Ultrasound enthesitis response score. This is a validated tool for assessing enthesitis in spondyloarthropathy. It assess both chronic a active features of enthesitis at the knee, plantar fascia, achilles tendon and triceps tendon. A total score of 136 can be achieved.
次要结局
- Relationship of baseline MASEI score to the clinical outcomes at baseline(4 months)
- The change in Minimal Disease Activity (MDA) response from baseline assessment(4 months)
- The change in 66/68 tender and swollen joint counts from baseline assessment(4 months)
- The change in Leeds Enthesitis Index (LEI) score from baseline assessment(4 months)
- Assess change in Ultrasound (US) findings at nail bed(4 months)
- The change in Dactylitis score from baseline assessment(4 months)
- The change in Psoriatic Arthritis Response Criteria (PsARC) response from baseline assessment(4 months)