Back to search

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Aiming for remission in RA: a randomized trial examining the benefit of ultrasonography in a clinical tight control regimen

Awarded: NOK 6.4 mill.

The rapid development of medical equipment to help physicians in their decision-making has led to fundamental changes in patient management throughout medical specialties. The implementation of new techniques in clinical practice is often based on the opportunity to assess pathologic findings thought to be of importance, but randomized clinical trials assessing the added value of new techniques on patient outcomes are often not undertaken before changing patient care. An increasing number of rheumatologists use ultrasound in the management of rheumatic diseases. Ultrasound can assess two aspects of synovitis: the morphology and quantity by grey-scale, and synovial vascularity by power Doppler, and structured ultrasound examination has been a promising tool for monitoring of disease activity in Rhematoid Arthritis. The randomized controlled ARCTIC trial was designed to examine if the use of a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis (RA), compared to a conventional tight-control strategy. Newly diagnosed disease-modifying anti-rheumatic drug (DMARD) naïve RA patients with indication for DMARD therapy were randomized to A) an ultrasound tight control strategy targeting clinical and imaging remission (no ultrasound power-Doppler signal) or B) a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same strategy, with 13 visits over 2 years. The primary endpoint was the proportion of patients with a combination between 16 and 24 months of: 1) Clinical remission 2) No swollen joints and 3) Non-progression of radiographic joint damage. A total of 238 patients were included. The trial was conducted at 11 centers in Norway between September 2010 and May 2015, in compliance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. All patients provided written informed consent. 22% of the patients in the ultrasound tight control arm and 19% of the patients in the clinical tight control arm reached the primary endpoint. Secondary endpoints (disease activity, physical function, and joint damage) and adverse events were similar between the two groups. The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology.

Background and objectives: The ultimate goal of rheumatoid arthritis (RA) treatment is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known. This study will assess if the use of a tre atment strategy incorporating information from ultrasonography (US) assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone. Methods: The study is designed as a randomized, multi- centre, prospective clinical trial of 2 years duration aiming at clinical and radiographic remission in patients with early RA. Treatment adjustments must be made according to a pre-specified dosing regimen, based on change in the Disease Activity Score ( DAS). In the ultrasonography group, the physician may overrule the decision based on the DAS and change therapy based on US findings. R&D challenges: US is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as MRI, including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of this approach in terms of patient outcomes has not been demonstrated. Thus, cla rification is needed if the use of US leads to better care for RA patients, and whether it is cost-effective. Application potential: The results of this study are expected to have a large international impact, regarding which treatment strategy should be applied in early RA to reach remission and halt radiographic progression. The results will have an impact on how rheumatology out-patient clinics should organize their care of RA-patients, and especially what place US should have in clinical practice. Re sults from the secondary analyses will provide important knowledge about prognostic factors, the burden of illness and important aspects of health economics related to treatment of early RA.

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering