2025-524593-42-00Not yet recruitingPhase 4
Tapering optimisation with placebo-based mechanisms in rheumatoid arthritis: the TOP-RA trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026
Brief summary (registry, in English)
To evaluate whether an expectation training, alone or combined with the conditioning regimen, can improve bDMARD tapering compared with regular care.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 231 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Oct 2026
- Lead sponsor
- Universiteit Leiden
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2025-524593-42-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 231
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rheumatoid arthritis who use an injected biologic DMARD and are willing to start lowering the dose. It tests whether expectation training helps with this tapering.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis diagnosed by a rheumatologist. The treating rheumatologist must consider the person ready to start tapering the biologic DMARD.
- Earlier treatment
- Must be using a biologic DMARD by injection pen, given every 7, 10, 14 or 21 days depending on the drug (abatacept, adalimumab, certolizumab, etanercept, infliximab, tocilizumab or sarilumab). It must be at full dose or after one DRESS step.
Main reasons for not taking part
- Cannot smell or has a severely reduced sense of smell
- Allergy or sensitivity to essential oils when inhaled
- Visual or hearing problems that prevent taking part in the trainings
- Wish to become pregnant in the upcoming year
- Currently in, or planning to join, another rheumatoid arthritis medication trial
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating or planning to participate in another RA medication trial.
Other illness
- Allergy or sensitivity to essential oils when inhaled.
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Netherlands | Not yet recruiting |
| Dijklander Ziekenhuis | Hoorn Nh | Netherlands | Not yet recruiting |
| Frisius MC | Leeuwarden | Netherlands | Not yet recruiting |
| Universiteit Leiden | Leiden | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
| Haga Hospital | 's-Gravenhage | Netherlands | Not yet recruiting |
| Stichting Viecuri Medisch Centrum voor Noord-Limburg | Venlo | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.