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: Theo Rispens, Ronald F. van Vollenhoven, Annick de Vries, Gerrit Jan Wolbink, Maarten Boers, Alfons A den Broeder, Michael T. Nurmohamed, Sadaf Atiqi, Maike H. M. Wientjes, Bart J F van den Bemt
Přispěvatelé: Rheumatology, AII - Inflammatory diseases, ACS - Atherosclerosis & ischemic syndromes, Epidemiology and Data Science, APH - Methodology, Clinical Immunology and Rheumatology, AMS - Musculoskeletal Health
Rok vydání: 2021
Předmět:
Medicine (General)
medicine.medical_specialty
Design
Drug concentration
Medicine (miscellaneous)
Therapeutic drug monitoring
Etanercept
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
law.invention
Arthritis
Rheumatoid
Anti-TNF
Study Protocol
03 medical and health sciences
All institutes and research themes of the Radboud University Medical Center
R5-920
0302 clinical medicine
Randomized controlled trial
Treatment trial
law
Internal medicine
Adalimumab
medicine
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Rheumatoid arthritis
Randomized Controlled Trials as Topic
030203 arthritis & rheumatology
Protocol (science)
medicine.diagnostic_test
Tumor Necrosis Factor-alpha
business.industry
Serum concentration
medicine.disease
Test-treatment trial
Treatment Outcome
Antirheumatic Agents
Switching
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
Trough level
Tumor Necrosis Factor Inhibitors
Drug Monitoring
business
medicine.drug
Zdroj: Trials, 22
Trials, Vol 22, Iss 1, Pp 1-9 (2021)
Wientjes, M H M, Atiqi, S, Wolbink, G J, Nurmohamed, M T, Boers, M, Rispens, T, de Vries, A, van Vollenhoven, R F, van den Bemt, B J F & den Broeder, A A 2021, ' 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 ', Trials, vol. 22, no. 1, 406, pp. 406 . https://doi.org/10.1186/s13063-021-05358-7
Trials, 22(1):406. BioMed Central
Trials, 22, 1
Trials
ISSN: 1745-6215
Popis: 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: OpenAIRE
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