Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis
PETSPA
The Efficacy of Adalimumab and Conventional Antirheumatic Drugs in Alleviating Axial and Aortic Inflammation Detected in PET/CT in Patients With Axial Spondyloarthritis
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 23, 2017
February 1, 2017
1.9 years
December 16, 2015
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
PET signals within groups
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.
16 weeks
Secondary Outcomes (1)
PET signals between groups
16 weeks
Study Arms (2)
DMARD-naive
ACTIVE COMPARATORSulfasalazine will be given as the initial therapy.
Post-sulfasalazine
EXPERIMENTALSulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- AbbViecollaborator
Study Sites (2)
Helsinki University Central Hospital
Helsinki, Finland
Päijät-Häme Central Hospital
Lahti, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 18, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 23, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share