EUCTR2015-000752-20-FI进行中（未招募）不适用
The efficacy of adalimumab and conventional antirheumatic drugs in alleviating axial and aortic inflammation detected in PET/CT in patients with axial spondyloarthritis - PETSPA
niversity of Helsinki0 个研究点开始时间: 2015年7月20日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. All the patients are required to fulfill the Assessment in SpondyloArthritis international Society (ASAS) classification criteria for radiographic axial spondyloarthritis, that is, that they have had >3 months of back pain, that they were less than 45 years at symptom onset, that they have sacroiliitis in imaging (MRI or X-ray according to modified New York criteria), and that they have one or more of the following features: dactylitis, positive family history of spondyloarthritis, inflammatory back pain, good response to NSAIDs, enthesitis, arthritis, raised CRP, HLA-B27, and uveitis.
- •Of the 60 patients, 20 are DMARD-naiive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug (those with methotrexate are excluded). The patients who are resistant to sulfasalazine are required to have an active disease despite sulfasalazine, determined as visual analogue scale (VAS) =4 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) =4.
- •An interim analysis will be made after 15 patients (pilot phase) to check the estimated parameter values used in the power calculation. Based on the number of patients typically involved in PET/CT studies, the number of patients can possibly be reduced from 60, which is the maximum number of patients to be recruited.
- •In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be drawn from the registries of the Turku and Helsinki PET centres. The exact number of these historical controls depends on how many of them can be found from the registry. In all, the study includes 110 patients, but only 60 patients will be scanned with PET/CT within the project. The controls will be matched as well as possible using age, sex and smoking.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Psoriaris or psoriasis arthropathy
- •Inflammatory bowel disease
- •Unwillingness to participate in the study with additional imaging protocols
- •Expected life-span less than <1 year
- •Diabetes (to improve the PET imaging quality)
- •Probable noncompliance
- •Age <18 years or >75 years
- •Contraindications for sulfasalazine or adalimumab
- •Methotrexate used within the previous 6 months
- •A biologic medicine used within the previous 6 months
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