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Comparative Study
, 20 (1), 226

Novel Optical Spectral Transmission (OST)-guided Versus Conventionally Disease Activity-Guided Treatment: Study Protocol of a Randomized Clinical Trial on Guidance of a Treat-To-Target Strategy for Early Rheumatoid Arthritis

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Comparative Study

Novel Optical Spectral Transmission (OST)-guided Versus Conventionally Disease Activity-Guided Treatment: Study Protocol of a Randomized Clinical Trial on Guidance of a Treat-To-Target Strategy for Early Rheumatoid Arthritis

N J Besselink et al. Trials.

Abstract

Background: Assessment 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/design: The 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.

Discussion: The 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 registration: Dutch Trial Register, NTR6388. Registered on 6 April 2017 ( NL50026.041.14 ). Protocol version 3.0, 19-01-2017.

Keywords: Optical spectral transmission (OST) treat-to-target; Randomized controlled trial (RCT); Rheumatoid arthritis; Tight-control treatment; remission.

Conflict of interest statement

Ethics approval and consent to participate

Dutch Trial Register, NTR6388. Registered on 6 April 2017 (NL50026.041.14). Protocol version 3.0, 19-01-2017. Medical Research Ethics Committee of the UMC Utrecht approved the protocol in accordance with the Medical Research Involving Human Subjects Act (WMO), and granted approval for all participating centres.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT figure, trial visits, and assessments
Fig. 2
Fig. 2
The HandScan user interface; total and individual optical joint scores. The total optical joint score of 9.43 (blue arrow) meets the HandScan remission criterion for total score. Individual optical joint criteria are shown below the picture. Three joints (green arrows) exceed the individual optical joint score criterion (> 1). Considering the HandScan remission criteria (total optical spectral transmission (OST) score ≤ 11 AND a maximum of one joint with OST > 1), this (test) patient is not in remission
Fig. 3
Fig. 3
Flowchart. Green boxes indicate assessment of remission. Brown boxes indicate medication dosage-related events (maintaining, intensifying, and tapering treatment). Red boxes indicate patient dropouts. Blue diamonds indicate decisions for patient-tailored treatment. Orange boxes refer to current medication dosages. Clinical remission is remission according to ACR/EULAR 2011 Boolean remission criteria [10]. HandScan remission remission is achieved if total optical spectral transmission (OST) score ≤ 11 AND a maximum of one joint with OST > 1. MTX methotrexate, LEF leflunomide, PRED prednisolone, HCQ hydroxychloroquine, aTNF tumour necrosis factor inhibitor, MTX at max maximum (tolerable) dose, i.e., 30 mg or lower, or maximal tolerable dose, AE adverse event or effect, ML medication level

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