Tocilizumab Dose Optimization in Rheumatoid Arthritis
Key facts
- Where
- Alkmaar, Amsterdam, Rotterdam és Ubbergen, HollandiaSee the 6 sites
- Phase
- 4. fázis
Where in Hollandia
- Noordwest Ziekenhuisgroep StichtingAlkmaar, HollandiaTaking people
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Reade revalidatie & reumatologie centrum te AmsterdamAmsterdam, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaTaking people
- Sint Maartenskliniek StichtingUbbergen, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Reade revalidatie & reumatologie centrum te Amsterdam
- Trial code
- EU 2025-520513-30-00
- Record updated
- 2025. január 16.
- Original description
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.Read full original descriptionShow less
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.