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PET/CT Imaging Study for Patients with Giant Cell Arteritis or Rheumatoid Arthritis Using Zirconium (89Zr) Crefmirlimab Berdoxam

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 two diseases: Giant Cell Arteritis and Rheumatoid Arthritis. These conditions involve inflammation, with Giant Cell Arteritis affecting the arteries and Rheumatoid Arthritis affecting the joints. The study will use a special imaging technique called Positron Emission Tomography (PET) combined with a CT scan to visualize inflammation in the body. The treatment being tested is a medication known as 89Zr-Df-crefmirlimab, which is a type of protein that helps highlight areas of inflammation during the scan.

The purpose of the study is to evaluate how well this medication can show inflammation in the arteries and joints of patients who have recently been diagnosed with Giant Cell Arteritis or have active Rheumatoid Arthritis. Participants will receive the medication through an intravenous (IV) injection, which means it will be administered directly into a vein. After receiving the medication, participants will undergo a PET/CT scan to capture images of their arteries and joints. This will help researchers understand how the medication is taken up in these areas and how it can be used to assess inflammation.

The study will follow participants over a period of time to monitor the uptake of the medication in their bodies. The main focus will be on measuring how much of the medication is absorbed in different arteries or joints, which is expressed in terms of standardized uptake values (SUVs). This information will help determine the effectiveness of the medication in highlighting inflamed areas, potentially leading to better diagnosis and treatment options for these conditions in the future.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current symptoms related to either giant cell arteritis or rheumatoid arthritis.
For giant cell arteritis, symptoms such as fatigue, fever, weight loss, or specific headaches are evaluated. For rheumatoid arthritis, the presence of arthritis in at least one joint is assessed.
Step 2
Medication stabilization
Participants must have a stable dose of any current medications, such as disease-modifying anti-rheumatic drugs (DMARDs) or non-steroidal anti-inflammatory drugs (NSAIDs), for at least four weeks before the study begins.
Step 3
Administration of Zr89
The study involves the administration of Zr89, an aqueous solution for intravenous use. This is given as an intravenous bolus, which means it is injected directly into a vein in a single, quick dose.
Step 4
PET/CT scan
After the administration of Zr89, a PET/CT scan is performed. This imaging technique helps visualize the uptake of the tracer in arteries or joints, providing important information about inflammation levels.
Step 5
Data collection and analysis
The primary focus is on measuring the tracer uptake in different regions of interest, such as arteries or joints. These measurements are expressed as standardized uptake values (SUVs), which indicate the concentration of radioactivity.
Step 6
Follow-up and conclusion
Participants may be required to attend follow-up appointments to monitor any changes or side effects. The study is expected to conclude by December 2026, with all data collected and analyzed by that time.

Who can join the trial?

14 criteria

For patients with giant cell arteritis (GCA):
- Must be older than 50 years.
- Have a blood test showing an erythrocyte sedimentation rate (ESR) of 50 mm/hr or higher, or a C-reactive protein (CRP) level of 10 mg/L or higher. These tests measure inflammation in the body.
- Show clinical symptoms of GCA at the time of joining the study, such as:
  - For large vessel GCA: symptoms like fatigue, fever, weight loss, night sweats, pain in limbs during activity, or pain in shoulders or hips with morning stiffness.
  - For cranial GCA: new headaches, scalp tenderness, changes in the temporal artery, vision loss related to blood flow issues, stroke, temporary loss of blood flow to the brain, or pain in the jaw or tongue when chewing.
  - Have imaging or biopsy results that match GCA findings at the time of joining the study.
  - Be able to attend study appointments and follow study requirements.
  - Be able to give informed consent, which means understanding and agreeing to participate in the study.
  - For patients with rheumatoid arthritis (RA):
    
    Must be at least 30 years old.
    Have a diagnosis of rheumatoid arthritis based on specific criteria from 2010.
    Have active disease as determined by a doctor, with arthritis in at least one wrist, knee, or ankle, and need to start or change treatment.
    Can be taking certain medications for RA, like disease-modifying anti-rheumatic drugs (DMARDS) and oral corticosteroids, as long as the dose has been stable for at least 4 weeks before joining the study.
    Can use non-steroidal anti-inflammatory drugs (NSAID), as long as the dose has been stable for at least 4 weeks before joining the study.
    Be able to attend study appointments and follow study requirements.
    Be able to give informed consent, which means understanding and agreeing to participate in the study.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients who have an active infection that requires treatment.
Patients who have been diagnosed with cancer within the last five years, except for certain types of skin cancer.
Patients who have uncontrolled high blood pressure or diabetes.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
UMCG
Verified
Groningen, The Netherlands

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Investigated drugs

89Zr-Df-crefmirlimab is a special imaging agent used in this study. It helps doctors see certain immune cells, called CD8 T cells, in the body using a type of scan called PET/CT. This is important for understanding how these cells are involved in conditions like giant cell arteritis and rheumatoid arthritis.

Zirconium (89Zr) Crefmirlimab Berdoxam

What is already known about the treatment

Crefmirlimab – Crefmirlimab is administered through intravenous infusion, allowing it to be directly delivered into the bloodstream. It is currently being studied in clinical trials, particularly for its use in imaging CD8 T cells in conditions like rheumatoid arthritis and giant cell arteritis. The main therapeutic indication is to assist in the diagnosis and monitoring of these inflammatory diseases. At the molecular level, crefmirlimab binds to CD8 T cells, which can then be visualized using positron emission tomography (PET) imaging. It is classified as a monoclonal antibody used for diagnostic purposes in medical imaging.

Investigated diseases

Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses through periods of flares and remissions, where symptoms can worsen or improve. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.
Giant Cell Arteritis
Giant cell arteritis is an inflammation of the lining of the arteries, most often affecting the arteries in the head. It can cause headaches, scalp tenderness, jaw pain, and vision problems. The condition is more common in older adults and can lead to serious complications if not managed. The inflammation can cause the arteries to narrow, reducing blood flow. Symptoms may develop gradually or suddenly, and the disease can affect other large arteries in the body. The cause is not fully understood, but it involves an abnormal immune response.