BMJ open · 2025
Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Pascart Tristan, Fautrel Bruno, Gottenberg Jacques-Eric, Ducoulombier Vincent, Richez Christophe, Truchetet Marie-Elise, Avouac Jérôme, Morel Jacques, Basch André, Cormier Grégoire, SUNSTAR Study Group, CRI-IMIDIATE Network, Houvenagel Eric, Mariette Xavier, Norberciak Laurène
Аннотация
INTRODUCTION: Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.
METHODS AND ANALYSIS: The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI<10, no use of rescue treatment after week 12 and no experimental treatment change, at weeks 12, 24 and 52.
ETHICS AND DISSEMINATION: Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.
TRIAL REGISTRATION NUMBER: NCT03227419 and EudraCT2017-000947-41.
METHODS AND ANALYSIS: The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI<10, no use of rescue treatment after week 12 and no experimental treatment change, at weeks 12, 24 and 52.
ETHICS AND DISSEMINATION: Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.
TRIAL REGISTRATION NUMBER: NCT03227419 and EudraCT2017-000947-41.
Предметные рубрики MeSH
FemaleHumansAbataceptAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidClinical Trials, Phase IV as TopicEquivalence Trials as TopicInjections, SubcutaneousMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeTumor Necrosis Factor Inhibitors