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

GSK0 sites10 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

•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

•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