Ankylosing Spondyloarthritis Clinical Trial
Official title:
The Efficacy of Adalimumab and Conventional Antirheumatic Drugs in Alleviating Axial and Aortic Inflammation Detected in PET/CT in Patients With Axial Spondyloarthritis
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.
n/a
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