[18F]FLUORO-PEG-FOLATE for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Patients must be at least 30 years of age\n- 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.\n- 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).\n- 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).\n- 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.\n- 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.\n- Patients must be able to adhere to the study appointments and other protocol requirements\n- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures."}

Exclusion criteria

• {"criterion_text":"- Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening.\n- Patients who received methotrexate and folic acid less than 7 days before tracer injection\n- Treatment with any investigational drug within the previous 3 months\n- Known pregnancy or breast feeding\n- Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion"}

Primary endpoints

• {"endpoint_text":"- Our main endpoint is the association between quantitative changes in Folate PET after 4 weeks of anti-TNF treatment and clinical response to therapy up to 26 weeks of treatment in patients with established RA. Clinical follow-up up to 26 weeks will be regarded as golden standard.","definition_or_measurement_approach":"Association between quantitative changes in whole-body [18F]PEG Folate PET/CT after 4 weeks and clinical response to anti-TNF therapy assessed up to 26 weeks; clinical follow-up to 26 weeks regarded as gold standard."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

2

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands