2024-513537-21-02RecruitingPhase 2
[18F]PEG-folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026
Brief summary (registry, in English)
The primary objective is to investigate the association between quantitative changes in whole body [18F]PEG Folate PET/CT (Folate PET) after 4 weeks and clinical response to anti-TNF therapy at 26 weeks of treatment in patients with clinically active established RA. The secondary objective is to relate quantitative Folate PET outcome after 4 weeks to histological changes in synovial tissue after 4 weeks of anti-TNF treatment (with a particular focus on macrophage infiltration and FRβ expression).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 27 Nov 2024
- Lead sponsor
- Amsterdam UMC Stichting
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-513537-21-02
- EudraCT number
- 2018-004429-94
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 2 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 active rheumatoid arthritis who have a clinical reason to start or restart anti-TNF treatment. A special scan (Folate PET/CT) is used to follow how treatment works.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Rheumatoid arthritis with active disease and arthritis in at least one joint that a biopsy can reach.
- Earlier treatment
- Anti-TNF treatment is needed (infliximab, etanercept, adalimumab or certolizumab). One earlier anti-TNF drug is allowed, but not if it did not work in the first 12 weeks. DMARDs, oral steroids up to 10 mg daily and NSAIDs are allowed at a stable dose for at least 4 weeks.
Main reasons for not taking part
- Steroid injections into the muscle or vein in the 4 weeks before screening
- Methotrexate and folic acid taken less than 7 days before the tracer injection
- Any investigational drug in the past 3 months
- Known pregnancy or breastfeeding
- Research-related radiation exposure of 5 mSv or more in the past year
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
- A potential subject who meets any of the following criteria will be excluded from participation in this study: - Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening. - Patients who received methotrexate and folic acid less than 7 days before tracer injection - Treatment with any investigational drug within the previous 3 months - Known pregnancy or breast feeding - Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion
Who the study is looking for
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients must be at least 18 years of age - Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of the American Rheumatism Association (ARA)13 and/or the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria. - Patients with clinically active disease as assessed by a physician; with arthritis in at least one joint accessible to synovial biopsy and have a clinical indication to (re)start with anti-TNF (either Infliximab, Etanercept, Adalimumab or Certolizumab). - Prior treatment with one anti-TNF agent (Adalimumab, Certolizumab, Etanercept, Golimumab or Infliximab) is permitted, but may not be a primary failure to any anti-TNF agent (defined as no response within the first 12 weeks of treatment). Patients restarting previously successful aTNF treatment after a >3 month period are also allowed, provided the initial reason for stopping treatment was not ineffectiveness (such as surgery or an infection). - Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroid up to 10 mg daily is allowed, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up. - Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up. - Patients must be able to adhere to the study appointments and other protocol requirements - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.