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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

• 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The association between quantitative changes in Folate PET after 4 weeks of<br /><br>anti-TNF treatment and clinical response to therapy up to 26 weeks of<br /><br>treatment in patients with established RA. Clinical follow-up up to 26 weeks<br /><br>will be regarded as golden standard. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The association between quantitative Folate PET tracer uptake in joint(s) and<br /><br>histological changes in synovial tissue over 4 weeks of anti-TNF treatment<br /><br>(with particular focus on macrophage infiltration, FRβ expression and<br /><br>macrophage polarization status). </p><br>

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