Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis

Ankylosing Spondyloarthritis Clinical Trial

— PETSPA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02634541
• Other study ID #: PETSPA
• Secondary ID: 2015-000752-20
• Status: Recruiting
• Phase: Phase 4
• First received: December 16, 2015
• Last updated: February 22, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Helsinki University
• Contact: Tuomo Nieminen, PhD, MD
• Phone: +358 50 910 5150
• Email: tuomo.vm.nieminen[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• A biologic medicine used within the previous 6 months

Related Conditions & MeSH terms

• Ankylosing Spondyloarthritis
• Inflammation
• Spondylarthritis
• Spondylitis, Ankylosing

Intervention

Drug:
• Adalimumab
Biologic drug

Other:
• PET/CT imaging
PET/CT imaging

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	AbbVie

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PET signals between groups	Comparison of the pre-treatment PET signals between the three groups: those with axial spondyloarthritis, historical healthy controls and the patients with coronary heart disease.	16 weeks