跳至主要内容
临床试验/NCT02634541
NCT02634541Unknown4 期

The Efficacy of Adalimumab and Conventional Antirheumatic Drugs in Alleviating Axial and Aortic Inflammation Detected in PET/CT in Patients With Axial Spondyloarthritis

University of Helsinki2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
60
试验地点
2
主要终点
PET signals within groups

研究概览

简要总结

Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission tomography (PET) is the most sensitive method to detect inflammatory foci in clinical practice. A few small studies have demonstrated that PET imaging together with computed tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic treatment. The current study is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before and after antirheumatic treatment of clinically active axial spondyloarthritis.

Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be taken as historical controls. All the axial spondyloarthritis patients are PET/CT scanned after inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based regimen for 12 weeks, which is the time point for a second PET scan for this subgroup. Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks, those with adalimumab will be scanned with PET/CT for the third time. The subgroup with active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients form a pilot group, which is used to check the validity of the power calculation.

The project will give essential new information on PET-detectable inflammation in the patients with axial spondyloarthritis. The results will be published in international publication series. The publications will form the basis for a doctoral thesis. Funding for the project comes from Abbvie Ltd.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.

排除标准

  • Psoriasis 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
  • Pregnancy
  • Age <18 years or >75 years
  • Contraindication for adalimumab
  • Methotrexate used within the previous 6 months
  • A biologic medicine used within the previous 6 months

研究组 & 干预措施

Post-sulfasalazine

Experimental

Sulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy.

干预措施: PET/CT imaging (Other)

DMARD-naive

Active Comparator

Sulfasalazine will be given as the initial therapy.

干预措施: PET/CT imaging (Other)

Post-sulfasalazine

Experimental

Sulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy.

干预措施: Adalimumab (Drug)

结局指标

主要结局

PET signals within groups

时间窗: 16 weeks

Decrease in PET signal levels both in major CV tissues (mean TBR in the whole aorta) and musculoskeletal tissues (lumbar spine and articular enthesitis as well as arthritis) after antirheumatic treatment. Thus the variables of most interest reflect intraindividual changes.

次要结局

  • PET signals between groups(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuomo Nieminen

Professor of Internal Medicine

University of Helsinki

研究点 (2)

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