Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): study protocol for a fully blinded randomised superiority test-treatment trial

Autor: Maike H. M. Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T. Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F. van Vollenhoven, Bart J. F. van den Bemt, Alfons A. den Broeder
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Trials, Vol 22, Iss 1, Pp 1-9 (2021)
Druh dokumentu: article
ISSN: 1745-6215
45953465
DOI: 10.1186/s13063-021-05358-7
Popis: Abstract Background A substantial proportion of rheumatoid arthritis (RA) patients discontinues treatment with tumour necrosis factor inhibitors (TNFi) due to inefficacy or intolerance. After the failure of treatment with a TNFi, treatment can be switched to another TNFi or a bDMARD with a different mode of action (non-TNFi). Measurement of serum drug concentrations and/or anti-drug antibodies (therapeutic drug monitoring (TDM)) may help to inform the choice for the next step. However, the clinical utility of TDM to guide switching has not been investigated in a randomised test-treatment study. Methods ADDORA-switch is a 24-week, multi-centre, triple-blinded, superiority test-treatment randomised controlled trial. A total of 84 RA patients failing adalimumab treatment (treatment failure defined as DAS28-CRP > 2.9) will be randomised in a 1:1 ratio to a switching strategy to either TNFi or non-TNFi based on adalimumab serum trough level (intervention group) or random allocation (control group). The primary outcome is the between-group difference in mean time-weighted DAS28 over 24 weeks. Discussion The trial design differs in many aspects from previously published and ongoing TDM studies and is considered the first blinded test-treatment trial using TDM in RA. Several choices in the design of this trial are described, and overarching principles regarding test-treatment trials and clinical utility of TDM are discussed in further detail. Trial registration Dutch Trial Register NL8210 . Registered on 3 December 2019 (CMO NL69841.091.19).
Databáze: Directory of Open Access Journals
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