The aim of the ARCTIC study was to assess whether a treatment strategy based on structured ultrasound assessment would provide better results in early arthritis compared to a conventional strategy. The study was a multicenter, open-label, two-armed, parallel group, randomized controlled strategy study, conducted at ten rheumatology departments and one specialist center in Norway.
The study was conducted from September 2010 to September 2015.
Inclusion of patients has been completed.
The study included 238 patients recruited between September 2010 and April 2013. Inclusion criteria were age 18-75 years, arthritis according to 2010 ACR/EULAR criteria for rheumatoid arthritis, not previously treated with disease-modifying anti-rheumatic drugs (DMARDs), indication for such treatment, and time from first reported swollen joint of less than two years.
Patients were randomized to follow-up with ultrasound with the goal of clinical and imaging-based remission (n=122) or a conventional close follow-up strategy with the goal of clinical remission (n=116). Both groups followed the same drug treatment strategy.
The primary endpoint was the proportion of patients with the combination of clinical remission, no swollen joints and no progression of radiographic joint damage between 16 and 24 months. Secondary outcomes included measures of disease activity, radiographic progression, function, quality of life and medical events. The results showed that 22% in the ultrasound group and 19% in the clinical control group reached the primary endpoint. The conclusion of the primary study was that systematic use of ultrasound in the follow-up of early rheumatoid arthritis, treated in line with current recommendations, is not justified based on the ARCTIC results. The study emphasizes the need for randomized trials assessing the clinical application of medical technology. A number of sub-studies have been conducted based on data from the ARCTIC study, and several of these sub-studies are still ongoing.