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Study on [18F]Fluoro-PEG-Folate PET Scans for Identifying Rheumatoid Arthritis Risk in Individuals with ACPA Positive Arthralgia

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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 individuals who have a condition known as ACPA positive arthralgia. This condition involves joint pain and is associated with a specific type of antibody found in the blood, which can be an early sign of developing rheumatoid arthritis, a chronic inflammatory disorder affecting the joints. The study uses a special imaging technique called positron emission tomography (PET) to identify people at risk of developing rheumatoid arthritis. The PET scan involves a solution called [18F]Fluor-PEG-Folate, which is injected into the body to help highlight areas of inflammation in the joints.

The purpose of the study is to see how well the PET scan can predict the development of rheumatoid arthritis in people with ACPA positive arthralgia. Participants will receive the PET scan and be monitored over a period of one year to see if they develop clinical arthritis, which means arthritis that can be diagnosed by a doctor. The study aims to determine how accurately the PET scan can identify those who are likely to develop arthritis.

During the study, participants will undergo a PET scan using the [18F]Fluor-PEG-Folate solution, which is administered through an injection into a vein. The study will track the participants' health over the course of a year to observe any changes in their condition. The results will help researchers understand the relationship between PET scan results and the likelihood of developing rheumatoid arthritis, potentially leading to earlier and more accurate identification of individuals at risk.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. 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 being 18 years or older, having a diagnosis of arthralgia, and a positive ACPA blood test result of 10 U/mL or higher.

    You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the procedures and potential risks involved.

  2. Step 2

    PET scan preparation

    You will be prepared for a **positron emission tomography (PET) scan**. This involves receiving an injection of a solution called **[18F]Fluor-PEG-Folate**. This solution is administered through a vein in your arm, a process known as intravenous administration.

    The purpose of this solution is to help highlight certain areas in your body during the scan, which will help in assessing your risk for developing rheumatoid arthritis.

  3. Step 3

    PET scan

    You will undergo a whole-body **PET scan**. This scan will take images of your body to identify any joints that may be at risk of developing arthritis.

    The scan is non-invasive and will require you to lie still for a period while the images are being taken.

  4. Step 4

    Follow-up visits

    After the initial scan, you will have follow-up visits over the course of one year. These visits are to monitor your health and any development of arthritis in your joints.

    During these visits, healthcare professionals will evaluate the results of your PET scan and discuss any changes in your condition.

  5. Step 5

    End of study

    At the end of the study period, which lasts for one year, a final assessment will be conducted to determine the outcomes of your participation.

    The study aims to evaluate the effectiveness of the PET scan in predicting the development of arthritis, based on the images taken during your initial scan.

Who can join the trial?

5 criteria

  • Patients must be 18 years of age or older.
  • Patients must be diagnosed with arthralgia (joint pain not caused by injury) by a physician.
  • Patients must have a positive ACPA blood test, which means a test result of 10 U/mL or higher. ACPA stands for anti-citrullinated protein antibodies, which are markers in the blood.
  • Patients must be able to attend all 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?

4 criteria

  • Individuals who do not have ACPA positive arthralgia cannot participate. ACPA stands for anti-citrullinated protein antibodies, which are markers in the blood that can indicate a risk for arthritis. Arthralgia means joint pain.
  • Participants must be within the specified age range. If you are not in the required age group, you cannot join the study.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

[18F]PEG-Folate is a special type of imaging agent used in a PET scan. This medication helps doctors see certain cells in the body that are involved in inflammation, which is a key part of rheumatoid arthritis. By targeting these cells, the PET scan can show areas in the body where there might be a risk of developing arthritis. This helps doctors identify individuals who might be at risk for rheumatoid arthritis, even before they show any symptoms. The goal is to catch the disease early and possibly prevent it from getting worse.

What is already known about the treatment

[18F]PEG-Folate – This medication is administered through an injection and is used in a specialized imaging technique called positron emission tomography (PET). It is currently being studied in clinical trials to assess its effectiveness in identifying individuals at risk for developing rheumatoid arthritis, particularly those with ACPA positive arthralgia. The main therapeutic indication is to help predict the onset of clinical arthritis by detecting inflammation in the joints. At the molecular level, [18F]PEG-Folate targets macrophages, which are cells involved in inflammation, allowing for visualization of active inflammation in the body. It is classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

ACPA Positive Arthralgia – ACPA positive arthralgia is a condition characterized by joint pain in individuals who test positive for anti-citrullinated protein antibodies (ACPA). These antibodies are often associated with an increased risk of developing rheumatoid arthritis. The joint pain experienced in ACPA positive arthralgia can vary in intensity and may affect different joints at different times. Over time, individuals with this condition may experience changes in joint function and mobility. The progression of ACPA positive arthralgia can lead to the development of clinical arthritis, where inflammation and swelling become more pronounced. Monitoring and understanding the progression of this condition is crucial for managing symptoms and preventing further joint damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513538-40-02Estimated enrolment60 patientsSponsorAmsterdam UMC Stichting

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