2024-517112-30-00Not yet recruitingPhase 4
Filgotinib bridging in newly diagnosed rheumatoid arthritis patients (FAST RA trial); A pragmatic randomized controlled non-inferiority low intervention clinical trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate non-inferiority and potential superiority in achieving disease activity remission at 3 months of bridging with a JAK inhibitor (Filgotinib 200 mg once daily for 3 months) versus bridging with corticosteroids (triamcinolone 120 mg single dose im) when starting with methotrexate and hydroxychloroquine therapy in rheumatoid arthritis patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 1 Jan 2025
- Lead sponsor
- Medisch Spectrum Twente
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-517112-30-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 168
- 1 site 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 newly diagnosed rheumatoid arthritis who have never taken disease-modifying drugs (DMARDs). It compares two short-term treatments given at the start of methotrexate and hydroxychloroquine therapy.
- Age
- 18 to 64 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed rheumatoid arthritis, diagnosed by a rheumatologist, with a DAS28-CRP score above 2.6 at the start.
- Earlier treatment
- Must never have taken DMARDs. No corticosteroids in the last three months.
Main reasons for not taking part
- Current or earlier treatment with DMARDs
- Risk of cardiovascular disease
- Risk of cancer, including current or long-term smoking
- Pregnancy, planned pregnancy or planning to father a child
- Corticosteroid use in the last three months
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
- Current or prior treatment with DMARDs
- Corticosteroid use in the last three months
Other illness
- Risk of cardiovascular diseases
- Risk of malignancies, including current smoking of having smoked for a long time
Other
- (Planned) pregnancy or planning to father a child
- Contra-indications for methotrexate, adalimumab, tocilizumab, hydroxychloroquine, triamcinolone, filgotinib or folic acid (protocol section 4.3)
Who the study is looking for
- Newly diagnosed rheumatoid arthritis patients according to a rheumatologist
- DMARD-naive
- Age 18 – 64 years old
- DAS28-CRP > 2.6 at the start of the study
- Dutch proficiency
- Signed informed consent
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
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 |
This page is information, not medical advice. Discuss any trial with your doctor.