Filgotinib bridging in newly diagnosed rheumatoid arthritis patients (FAST RA trial); A pragmatic randomized controlled non-inferiority low intervention clinical trial
Key facts
- Where
- Enschede, HollandiaSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Hollandia
- Medisch Spectrum TwenteEnschede, 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
- Medisch Spectrum Twente
- Trial code
- EU 2024-517112-30-00
- Record updated
- 2025. január 16.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Current or prior treatment with DMARDs; Corticosteroid use in the last three months; Risk of cardiovascular diseases; Risk of malignancies, including current smoking of having smoked for a long time; (Planned) pregnancy or planning to father a child; Contra-indications for methotrexate, adalimumab, tocilizumab, hydroxychloroquine, triamcinolone, filgotinib or folic acid (protocol section 4.3).