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Taking people in NetherlandsPhase 4

Tocilizumab Dose Optimization in Rheumatoid Arthritis

EU 2025-520513-30-00 · Run by Reade revalidatie & reumatologie centrum te Amsterdam · Record updated 16 January 2025

Where in Netherlands

  • Alkmaar · Noordwest Ziekenhuisgroep StichtingTaking people
  • Amsterdam · Amsterdam UMC StichtingTaking people
  • Amsterdam · Reade revalidatie & reumatologie centrum te AmsterdamTaking people
  • Rotterdam · Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Taking people
  • Rotterdam · Maasstad Ziekenhuis StichtingTaking people
  • Ubbergen · Sint Maartenskliniek StichtingTaking people
The registry text, word for word

Concentration guided dose reduction versus standard dosing in tocilizumab treated heumatoid arthritis patients:a randomised, international, multicenter, non-inferiority trial

The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) in patients with RA with serum trough concentrations higher than 15 mg/L who are randomly assigned to continuation of the standard dose or to increase dosing interval to every two weeks.

Inclusion: Rheumatoid arthritis according to the ACR 1987 or 2010 criteria; Current use of subcutaneous tocilizumab 162 mg weekly , for at least the last 6 months; The treating rheumatologist is convinced of the benefit of tocilizumab continuation; No changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months; Written informed consent.

Exclusion: A scheduled surgery in the next 52 weeks or other pre-planned reasons for treatment discontinuation.

EU CTIS 2025-520513-30-00