arthritis Rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion 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 synovial biopsy accessible joint and have a clinical indication to start or restart (if stopped >12 weeks) 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) • 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
Exclusion criteria: • 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The association between quantitative Folate PET tracer uptake in joint(s) and histological changes in synovial tissue over 4 weeks of anti-TNF treatment (with particular focus on macrophage infiltration, FRβ expression and macrophage polarization status). | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed