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Study on Axial Spondyloarthritis Treatment Using Technetium-Labeled Certolizumab Pegol for Patients with Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying axial spondyloarthritis, a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. The trial will use a treatment called Technetium-labeled certolizumab pegol, which is a solution for injection. This treatment involves a special protein that is labeled with a radioactive substance called technetium, which helps doctors see how the treatment is working inside the body through imaging techniques.

The purpose of the study is to improve the way doctors assess the activity of the disease and predict how well patients will respond to treatment. Participants in the study will receive the treatment and undergo imaging tests to see how the disease is progressing. The study will compare the results of these imaging tests with other standard methods to determine if the new approach provides better information about the disease.

Throughout the study, participants will be monitored for changes in their condition over a period of several weeks. The study aims to see if the new imaging method can help doctors make better treatment decisions and improve outcomes for patients with axial spondyloarthritis. The trial will also look at how the treatment affects patients’ quality of life and overall health.

1 joining the study

Upon joining the study, you will provide your informed, written consent to participate. This is a necessary step to ensure that you understand the study and agree to be part of it.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, diagnosis of axial spondyloarthritis, and previous treatment responses. Your CRP level (a marker of inflammation) will be checked if it was not assessed in the last three months.

3 imaging and baseline tests

You will undergo magnetic resonance imaging (MRI) if it has not been done in the last three months. This helps in assessing the current state of your condition. Additionally, a special imaging test called immunoscintigraphy will be performed using 99mTc Certolizumab Pegol, which is a solution injected into your vein to help visualize inflammation.

4 treatment initiation

Based on the results of the imaging tests and discussions with your rheumatologist, a decision will be made to start treatment with a biologic disease-modifying antirheumatic drug (bDMARD) or a targeted synthetic disease-modifying antirheumatic drug (tsDMARD). The specific medication, dosage, and frequency will be determined by your healthcare provider.

5 follow-up assessments

You will have follow-up assessments at approximately 12 weeks and 24 weeks after starting the treatment. These assessments will include evaluating your response to the treatment using the Ankylosing Spondylitis Disease Activity Score (ASDAS) and other measures of disease activity. Your progress will be monitored through questionnaires and laboratory tests.

6 final evaluation

At the end of the study period, a final evaluation will be conducted to assess the overall effectiveness of the treatment strategy. This will include a review of your imaging results, disease activity scores, and any changes in your condition.

Who Can Join the Study?

  • The patient must provide their written consent to participate in the study.
  • Male patients whose partners can become pregnant should either be surgically sterile or use a condom during intercourse until 35 days after the last scan.
  • The patient must be between 18 and 85 years old.
  • The patient must have a documented diagnosis of axial spondyloarthritis that meets specific classification criteria.
  • The patient must meet the criteria for starting certain medications for axial spondyloarthritis, as per Belgian guidelines.
  • The decision to start therapy with specific medications must be a shared decision between the patient and their rheumatologist (a doctor specializing in joint diseases).
  • An MRI (a type of scan that uses magnetic fields to create images of the body) must have been performed no more than 3 months before the screening visit.
  • The patient’s CRP level (a blood test that measures inflammation) must be greater than 5 mg/L, with the test done no more than 3 months before the screening visit.
  • The patient must have a documented insufficient response to treatment with two NSAIDs (non-steroidal anti-inflammatory drugs) at optimal doses.
  • Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Axial Spondyloarthritis cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.06.2024

Trial locations

Investigated drugs:

Certolizumab Pegol is a medication used in this clinical trial. It is a type of drug known as a biologic, which means it is made from living organisms or their products. Certolizumab Pegol works by blocking a specific protein in the body called tumor necrosis factor (TNF). TNF is involved in causing inflammation, which is a key part of the disease process in conditions like axial spondyloarthritis. By blocking TNF, Certolizumab Pegol helps reduce inflammation and can improve symptoms such as pain and swelling. In this trial, the medication is labeled with a substance called Technetium, which helps doctors see how the drug is working in the body using special imaging techniques.

Investigated diseases:

Axial Spondyloarthritis – Axial Spondyloarthritis is a chronic inflammatory disease primarily affecting the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by inflammation that can lead to pain and stiffness, particularly in the lower back and buttocks. Over time, the inflammation can cause new bone formation, leading to the fusion of the vertebrae, which may result in reduced flexibility and mobility. The disease often begins in early adulthood and can progress slowly, with periods of increased symptoms and periods of remission. In some cases, it may also affect other joints and organs, such as the eyes and skin. The progression and severity of symptoms can vary widely among individuals.

Trial ID:
2023-505694-32-00
Protocol code:
SCINTRA-3
Trial Phase:
Therapeutic confirmatory (Phase III)

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