[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NL-OMON26919
- Lead Sponsor
- GSK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The tracer uptake in different joints whereby the radioactivity concentration in ROIs are expressed as SUV.
- Secondary Outcome Measures
Name Time Method The association between quantitative Folate PET tracer uptake in joint(s) and histological changes in synovial tissue over 4 weeks of anti-TNF treatment