Abstract
BackgroundAssessment of disease activity is a critical component of tight-control, treat-to-target treatment strategies of rheumatoid arthritis (RA). Recently, the HandScan has been validated as a novel method for objectively assessing RA disease activity in only 1.5 min, using optical spectral transmission (OST) in hands and wrists. We describe the protocol of a randomized controlled clinical trial (RCT) to investigate whether HandScan-guided treatment aimed at ‘HandScan remission’ (HandScan arm) is at least as effective as and more cost-effective than clinically guided treatment aimed at ACR/EULAR 2011 Boolean remission (DAS arm).Methods/designThe study is a multi-center, double-blind, non-inferiority RCT of 18 months duration. Patients ≥ 18 years with newly diagnosed, disease-modifying antirheumatic drug (DMARD)-naïve RA according to the ACR 2010 classification criteria, will be randomized to the DAS arm or the HandScan arm. The efficacy of the arms will be compared by evaluating Health Assessment Questionnaire (HAQ) scores (primary outcome) after 18 months of DMARD therapy, aimed at remission. The equivalence margin in HAQ scores between study arms is 0.2. Secondary outcomes are differences in cost-effectiveness and radiographic joint damage between treatment arms. The non-inferiority sample size calculation to obtain a power of 80% at a one-sided p value of 0.05, with 10% dropouts, resulted in 61 patients per arm. In both arms, DMARD strategy will be intensified monthly according to predefined steps until remission is achieved; in both arms DMARDs and treatment steps are identical. If sustained remission, defined as remission that persists consistently over three consecutive months, is achieved, DMARD therapy will be tapered.DiscussionThe study protocol and the specifically designed decision-making software application allow for implementation of this RCT. To test a novel method of assessing disease activity and comparing (cost-)effectiveness with the contemporary method in treat-to-target DMARD strategies in early RA patients.Trial registrationDutch Trial Register, NTR6388. Registered on 6 April 2017 (NL50026.041.14). Protocol version 3.0, 19-01-2017.
Highlights
Assessment of disease activity is a critical component of tight-control, treat-to-target treatment strategies of rheumatoid arthritis (RA)
HandScan correlates moderately with ultrasound (US) assessing synovial inflammation of hand and wrist joints (Spearman’s correlation coefficient, ρ = 0.54, 95% CI 0.28 to 0.73, p < 0.01), while DAS28 did not correlate with these US results (ρ = 0.06, 95% CI − 0.26 to 0.36, p = 0.71) [7]
This study aims to evaluate clinical efficacy of a HandScan-guided versus Disease Activity Score (DAS)-guided tight-control and treat-to-target treatment strategy for early RA
Summary
Assessment of disease activity is a critical component of tight-control, treat-to-target treatment strategies of rheumatoid arthritis (RA). The HandScan has been validated as a novel method for objectively assessing RA disease activity in only 1.5 min, using optical spectral transmission (OST) in hands and wrists. The aim of tight-control treatment, i.e., tailoring treatment strategy to the disease activity of individual patients, is to achieve a predefined level of low disease activity, preferably remission (treat-to-target), within a reasonable period of time. For tight-control and treat-to-target treatment strategies for the treatment of RA, typically frequent disease activity assessment is applied using the Disease Activity Score (DAS), a composite score of an acute phase reactant, such as C-reactive protein (CRP), patient global assessment (PGA), and swollen and tender joint counts (SJC and TJC, respectively) of 28 or 44 joints. HandScan has proven to be user-friendly—i.e., an assistant without medical background can operate the device—and fast (it provides the inflammation score within 1.5 min)
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