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Clinical Trials/NCT02634541
NCT02634541
Unknown
Phase 4

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 sites in 1 country60 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
PET/CT imaging
Conditions
Ankylosing Spondyloarthritis
Sponsor
University of Helsinki
Enrollment
60
Locations
2
Primary Endpoint
PET signals within groups
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tuomo Nieminen

Professor of Internal Medicine

University of Helsinki

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Post-sulfasalazine

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

Intervention: PET/CT imaging

DMARD-naive

Sulfasalazine will be given as the initial therapy.

Intervention: PET/CT imaging

Post-sulfasalazine

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

Intervention: Adalimumab

Outcomes

Primary Outcomes

PET signals within groups

Time Frame: 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.

Secondary Outcomes

  • PET signals between groups(16 weeks)

Study Sites (2)

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