The efficacy of adalimumab and sulfasalazine in alleviating inflammation detected in PET/CT imaging in patients with axial spondyloarthritis

Active, not recruiting

• Conditions: Axial and aortic inflammation detected in PET/CT imaging in patients with axial spondyloarthritis; MedDRA version: 18.0Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000752-20-FI
• Lead Sponsor: niversity of Helsinki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. All the patients are required to fulfill the Assessment in SpondyloArthritis international Society (ASAS) classification criteria for radiographic axial spondyloarthritis, that is, that they have had >3 months of back pain, that they were less than 45 years at symptom onset, that they have sacroiliitis in imaging (MRI or X-ray according to modified New York criteria), and that they have one or more of the following features: dactylitis, positive family history of spondyloarthritis, inflammatory back pain, good response to NSAIDs, enthesitis, arthritis, raised CRP, HLA-B27, and uveitis.

Of the 60 patients, 20 are DMARD-naiive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug (those with methotrexate are excluded). The patients who are resistant to sulfasalazine are required to have an active disease despite sulfasalazine, determined as visual analogue scale (VAS) =4 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) =4.

An interim analysis will be made after 15 patients (pilot phase) to check the estimated parameter values used in the power calculation. Based on the number of patients typically involved in PET/CT studies, the number of patients can possibly be reduced from 60, which is the maximum number of patients to be recruited.

In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be drawn from the registries of the Turku and Helsinki PET centres. The exact number of these historical controls depends on how many of them can be found from the registry. In all, the study includes 110 patients, but only 60 patients will be scanned with PET/CT within the project. The controls will be matched as well as possible using age, sex and smoking.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Psoriaris 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
•Contraindications for sulfasalazine or adalimumab
•Methotrexate used within the previous 6 months
•A biologic medicine used within the previous 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified