[18F]PEG-folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients must be at least 30 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.

Exclusion Criteria

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

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Amsterdam UMC Stichting
🇳🇱
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱
Groningen, Netherlands
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Conny van der Laken
Site contact
0205662694
reumatologie@vumc.nl