Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
研究概览
简要总结
Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.
The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.
The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Planning to start anti-TNF alpha treatment
排除标准
- •Patients not being able to communicate in Norwegian or not being able to fill in questionnaires
- •Surgery in more than 5 of the joints/entheses to be examined by US
结局指标
主要结局
To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
时间窗: Including patients for about 1.5 years
The joints will be assessed according to a US atlas by use of a semi-quantitative (0-3) scoring system and the entheses will be evaluated according to internationally accepted scoring methods.
次要结局
- 5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.(2.5 years)
- 3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.(2.5 years)
- 1. Explore whether the US (B-mode and power Doppler) scores at baseline or after 3 months predict patients responding to biological treatment after 6 and 12 months.(2.5 years)
- 4. Explore whether the different subgroups of spondylarthritis patients have different US response (B-mode synovitis and power Doppler in joints and entheses) to biological treatment.(2.5 years)
- 2. Explore whether the sensitivity for change is higher for US (B-mode and/or power Doppler) than for the traditional assessments for inflammatory activity.(2.5 years)
- 6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.(2.5 years)
- 7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.(2.5 years)
研究者
Hilde Berner Hammer
Senior consultant, PhD
Diakonhjemmet Hospital