Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.

Phase 1

• Conditions: Rheumatoid Arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-004429-94-NL
• Lead Sponsor: VU Medical Center, department of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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 knee or ankle joint and have a clinical indication to start with anti-TNF (either Infliximab, Etanercept, Adalimumab or Certolizumab)
• Prior treatment with one anti-TNF agent 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate the association between quantitative changes in whole body F-18-PEG Folate PET/CT (Folate PET) after 4 weeks and clinical response to anti-TNF therapy at 26 weeks of treatment in patients with clinically active established |RA. ;Secondary Objective: The secondary objective is to relate quantitative Folate PET outcome after 4 weeks to histological changes in synovial tissue after 4 weeks of anti-TNF treatment (with a particular focus on macrophage infiltration and FRß expression).;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Two years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 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, FRß expression and macrophage polarization status). ;Timepoint(s) of evaluation of this end point: Two years