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

Autor: F.P.J.G. Lafeber, J M van Woerkom, Antonius A A Westgeest, Mihaela Gamala, Ruth Klaasen, Maxime M A Verhoeven, W.E. van Spil, A.C.A. Marijnissen, Janneke Tekstra, J.M. van Laar, J. W. G. Jacobs, Nicolle Besselink
Rok vydání: 2019
Předmět:
Wrist Joint
Time Factors
Spectral transmission
Cost-Benefit Analysis
Medicine (miscellaneous)
Severity of Illness Index
law.invention
Arthritis
Rheumatoid
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Multicenter Studies as Topic
Medicine
Pharmacology (medical)
030212 general & internal medicine
Tight-control treatment
skin and connective tissue diseases
Netherlands
lcsh:R5-920
Optical Imaging
Remission Induction
Health Care Costs
Treatment Outcome
Antirheumatic Agents
Rheumatoid arthritis
Treatment study
lcsh:Medicine (General)
musculoskeletal diseases
medicine.medical_specialty
Hand Joints
Clinical Decision-Making
Equivalence Trials as Topic
Disease activity
03 medical and health sciences
remission
Double-Blind Method
Predictive Value of Tests
Internal medicine
Optical spectral transmission (OST) treat-to-target
Journal Article
Humans
Protocol (science)
business.industry
medicine.disease
Clinical trial
Sample size determination
Randomized controlled trial (RCT)
business
030217 neurology & neurosurgery
Zdroj: Trials, 20(1). BioMed Central
Trials
Trials, Vol 20, Iss 1, Pp 1-10 (2019)
ISSN: 1745-6215
Popis: 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3285-8) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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