Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis

NCT ID: NCT02634541

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Ankylosing Spondyloarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DMARD-naive

Sulfasalazine will be given as the initial therapy.

Group Type: ACTIVE_COMPARATOR

PET/CT imaging

Intervention Type: OTHER

PET/CT imaging

Post-sulfasalazine

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

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: DRUG

Biologic drug

PET/CT imaging

Intervention Type: OTHER

PET/CT imaging

Interventions

Adalimumab

Biologic drug

Intervention Type: DRUG

PET/CT imaging

PET/CT imaging

Intervention Type: OTHER

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
• A biologic medicine used within the previous 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Tuomo Nieminen

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Site Status: RECRUITING

Päijät-Häme Central Hospital

Lahti, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Tuomo Nieminen, PhD, MD

Role: CONTACT

tuomo.vm.nieminen@helsinki.fi

+358 50 910 5150

Anne Kerola, BMS

Role: CONTACT

anne.kerola@helsinki.fi

+358 50 360 0550

Facility Contacts

Tuomo Nieminen

Role: primary

tuomo.vm.nieminen@helsinki.fi

Anne Kerola

Role: primary

anne.kerola@helsinki.fi

Other Identifiers

2015-000752-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PETSPA

Identifier Type: -

Identifier Source: org_study_id