Tapering optimisation with placebo-based mechanisms in rheumatoid arthritis: the TOP-RA trial
Key facts
- Where
- 's-Gravenhage, Enschede, Hoorn Nh, Leeuwarden, Leiden, Rotterdam és Venlo, HollandiaSee the 7 sites
- Phase
- 4. fázis
Where in Hollandia
- Haga Hospital's-Gravenhage, HollandiaToborzás még nem indult
- Medisch Spectrum TwenteEnschede, HollandiaToborzás még nem indult
- Dijklander ZiekenhuisHoorn Nh, HollandiaToborzás még nem indult
- Frisius MCLeeuwarden, HollandiaToborzás még nem indult
- Universiteit LeidenLeiden, HollandiaToborzás még nem indult
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaToborzás még nem indult
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, HollandiaToborzás még nem indult
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
- Universiteit Leiden
- Trial code
- EU 2025-524593-42-00
- Record updated
- 2026. október 5.
- Original description
To evaluate whether an expectation training, alone or combined with the conditioning regimen, can improve bDMARD tapering compared with regular care.Read full original descriptionShow less
To evaluate whether an expectation training, alone or combined with the conditioning regimen, can improve bDMARD tapering compared with regular care.
Inclusion: Adult (minimum age of 18 years); Being able to give informed consent; Fluent in Dutch (understanding, speaking, and reading); Diagnosed with rheumatoid arthritis by a rheumatologist; Using a biologic DMARDs via an injection pen which is administered weekly or biweekly on a full dose either on that full dose or after one DRESS step such as: . abatacept, administered every 7 or 10 days; . adalimumab, administered every 14 or 21 days; . certolizumab, administered every 14 or 21 days; . etanercept, administered every 7 or 10 days; . Infliximab, administered every 14 or 21 days; . tocilizumab, administered 7 or 10 days; . or sarilumab, administered every 14 or 21 days; Treating rheumatologist considers the patient eligible to start bDMARD tapering; Patient is willing to start bDMARD tapering; Having access to a device with internet (such as a computer, smartphone, or tablet).
Exclusion: Currently participating or planning to participate in another RA medication trial; Allergy or sensitivity to essential oils when inhaled; Inability to perceive odours or has a severely reduced olfactory function; An inability to open the smell stick, which is comparable to opening a small bottle or a marker, leading to exclusion only when no support person is available to provide assistance once a week; Any visual or auditory impairments that prevent participation in the trainings; Insufficient cognitive function or inadequate digital skills that prevent participation in training tasks, leading to exclusion only when no support person is available to provide assistance; Wish to become pregnant in the upcoming year.