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Study on [18F]Fluoro-PEG-Folate PET-CT Imaging to Monitor Therapy Response in Patients with Rheumatoid Arthritis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Rheumatoid Arthritis, a condition that causes inflammation in the joints, leading to pain and stiffness. The study will use a special imaging technique called [18F]PEG-folate PET-CT to monitor how patients with this condition respond to a type of treatment known as anti-TNF therapy. Anti-TNF therapy involves medications that help reduce inflammation by blocking a protein called tumor necrosis factor (TNF) in the body.

The purpose of the study is to see if changes in the PET-CT images after four weeks of treatment can predict how well patients will respond to the therapy after 26 weeks. The study will also look at changes in the joint tissue to understand more about how the treatment works, especially focusing on certain cells called macrophages and a protein known as FRβ.

Participants in the study will receive the [18F]Fluor-PEG-Folate solution through an intravenous infusion, which means it will be injected into a vein. The study will follow patients over a period of time to observe the effects of the treatment and the changes in their condition. Some participants may receive a placebo, which is a substance with no active medication, to compare the results. The study aims to provide valuable insights into the effectiveness of anti-TNF therapy for people with rheumatoid arthritis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will confirm your eligibility based on specific criteria, such as age and diagnosis of rheumatoid arthritis. You will be asked to provide informed consent, which means you agree to participate after understanding the study details.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate your current health status. This may include a physical examination, blood tests, and imaging tests like PET-CT scans. These tests help establish a starting point for monitoring changes during the study.
Step 3
Start of treatment
You will begin treatment with an anti-TNF medication, which could be Infliximab, Etanercept, Adalimumab, or Certolizumab. The specific medication and dosage will be determined by your healthcare provider. This treatment aims to manage symptoms of rheumatoid arthritis.
Step 4
Four-week follow-up
After four weeks of treatment, you will return for a follow-up visit. During this visit, another PET-CT scan will be performed to assess any changes in your condition. This scan helps evaluate the effectiveness of the treatment.
Step 5
Continuation of treatment
You will continue the anti-TNF treatment for a total of 26 weeks. Regular check-ups will be scheduled to monitor your progress and adjust treatment if necessary. It is important to adhere to the prescribed medication schedule and attend all appointments.
Step 6
Final assessment
At the end of the 26-week period, a final assessment will be conducted. This will include a physical examination, blood tests, and a final PET-CT scan. The results will help determine the overall effectiveness of the treatment and any changes in your condition.

Who can join the trial?

10 criteria

Patients must be at least 30 years of age.
Must have a diagnosis of rheumatoid arthritis based on specific medical criteria.
Must have active arthritis in at least one joint that can be accessed for a synovial biopsy (a procedure where a small sample of tissue is taken from the joint).
Must have a medical reason to start or restart treatment with anti-TNF therapy (a type of medication used to reduce inflammation).
Previous treatment with one anti-TNF medication is allowed, but it should not have been ineffective within the first 12 weeks.
Patients can restart a previously successful anti-TNF treatment if it was stopped for reasons other than ineffectiveness, like surgery or infection, and if more than 3 months have passed since stopping.
Use of disease-modifying anti-rheumatic drugs (DMARDs) and oral corticosteroids (up to 10 mg daily) is allowed if the dose has been stable for at least 4 weeks before joining the study and remains stable during the study for up to 12 weeks.
Use of non-steroidal anti-inflammatory drugs (NSAIDs) is allowed if the dose has been stable for at least 4 weeks before joining the study and remains stable during the study for up to 12 weeks.
Patients must be able to attend study appointments and follow the study requirements.
Patients must be able to give informed consent, meaning they understand the study and agree to participate before any study-related procedures begin.

Who cannot join the trial?

6 criteria

Patients who are not diagnosed with Rheumatoid Arthritis cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to undergo the required imaging tests, such as [18F]PEG Folate PET/CT, cannot participate. This is a special type of scan used to see inside the body.
Patients who have not shown a clinical response to anti-TNF therapy in the past cannot participate. Anti-TNF therapy is a treatment that helps reduce inflammation in the body.
Patients who cannot undergo a biopsy of the synovial tissue cannot participate. Synovial tissue is the soft tissue found in the joints.

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Verified sites

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Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Universitair Medisch Centrum Groningen
Groningen, The Netherlands

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Investigated drugs

[18F]PEG-folate
is a special imaging agent used in a type of scan called PET-CT. This agent helps doctors see certain areas of the body more clearly. In this trial, it is used to monitor how well patients with Rheumatoid Arthritis are responding to their treatment. The scan can show changes in the body that might indicate whether the treatment is working.
Anti-TNF therapy
is a type of treatment used for Rheumatoid Arthritis. It works by blocking a substance in the body called TNF, which is involved in inflammation and can cause joint damage. By reducing the activity of TNF, this therapy helps decrease inflammation and pain, and can improve joint function in patients with Rheumatoid Arthritis. In this trial, the effectiveness of anti-TNF therapy is being evaluated by looking at changes in the body using the special imaging agent.

[18F]Fluoro-Peg-Folate

What is already known about the treatment

[18F]PEG-folate – This medication is administered through a PET-CT scan, a type of imaging test that helps doctors see how the body is functioning. It is currently being studied in clinical trials to see how well it can monitor the response to therapy in patients with Rheumatoid Arthritis. The main use of this medication is to help doctors understand how well a patient's treatment is working by looking at changes in the body over time. At the molecular level, it works by targeting specific areas in the body that are affected by the disease, allowing doctors to see these areas more clearly on the scan. It is classified as a diagnostic imaging agent, which means it is used to help diagnose or monitor medical conditions.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid Arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation in the synovial membrane, which lines the joints, leading to swelling and pain. Over time, this inflammation can cause damage to the cartilage and bone within the joint, resulting in joint deformity and loss of function. The disease often progresses symmetrically, meaning it affects the same joints on both sides of the body. In addition to joint issues, it can also cause systemic symptoms such as fatigue and fever. The progression of the disease can vary, with periods of increased activity (flares) and periods of remission.