Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
GSK
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be at least 30 years of age Diagnosis of RA according to the 1987 revised criteria of the ARA13 and/or the 2019 ACR/EULAR RA classification criteria Patients with clinically active disease as assessed by a physician; with arthritis in at least one knee or ankle joint and have a clinical indication to start with anti-TNF Prior treatment with one anti-TNF agent is permitted, but may not be a primary failure to any anti-TNF agent Treatment with DMARDs and oral corticosteroid up to 10mg 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 NSAIDs are 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 acids 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
Primary
| Measure | Time frame |
|---|---|
| The tracer uptake in different joints whereby the radioactivity concentration in ROIs are expressed as SUV. | — |
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 | — |
Contacts
Public ContactJerney de Jongh
VUmc
Outcome results
None listed