Ongoing Clinical Trials for Takayasu’s Arteritis
There is currently 1 ongoing clinical trial for Takayasu’s arteritis, a rare inflammatory disease affecting large blood vessels. This trial is comparing two treatments, Infliximab and Tocilizumab, for patients whose disease is difficult to control or has returned after previous treatment. The trial is being conducted in France.
Clinical trial locations
- France
Study on Infliximab and Tocilizumab for Patients with Refractory or Relapsing Takayasu Arteritis
This trial is designed for patients with Takayasu’s arteritis that has not responded well to standard treatments or has come back after a period of improvement. The disease causes inflammation in large blood vessels, primarily the aorta and its main branches, which can lead to narrowing of these vessels and reduced blood flow to various parts of the body.
Who can participate:
- Patients aged 15 years or older with a confirmed diagnosis of Takayasu’s arteritis
- Individuals weighing between 40 and 120 kg
- Those currently receiving care in a hospital in France and having social insurance
- Patients with active disease that is difficult to treat or has severe symptoms affecting the arteries
- Those currently taking one immunosuppressive medication (such as methotrexate or azathioprine) at a stable dose for at least 30 days
- Recent chest X-ray or CT scan showing no active tuberculosis, infection, or cancer
- Negative tests for HIV, hepatitis B, and hepatitis C within the last three months
- For women of childbearing age, a negative pregnancy test and willingness to use contraception during the study and for 12 months after
Who cannot participate:
- Patients with other serious health conditions that could interfere with the study
- Those currently participating in another clinical trial
- Patients with recent infections that could affect study results
- Women who are pregnant or breastfeeding
- Individuals with a history of allergic reactions to the study medications
- Those with a history of drug or alcohol abuse
- Patients with mental health conditions that could interfere with participation
- Those diagnosed with cancer within the last five years
- Patients who have had major surgery within the last three months
Trial focus and goals:
The study aims to compare the effectiveness and safety of two treatments: Infliximab and Tocilizumab. Both medications are given through an infusion into a vein and work by reducing inflammation in the body, though they target different proteins involved in the immune response. Infliximab blocks tumor necrosis factor-alpha (TNF-alpha), while Tocilizumab inhibits the interleukin-6 (IL-6) receptor.
Participants are randomly assigned to receive one of these two medications and will be monitored over a 6-month treatment period. The main goal is to see if patients can maintain inactive disease while taking a low dose of a steroid medication called prednisone (or prednisolone) at 0.1 mg/kg per day or less. Throughout the study, regular check-ups will assess disease activity, how well the treatment works, and whether there are any side effects. The study will also track how often the disease relapses and evaluate participants’ quality of life.
What happens during the study:
After confirming eligibility and obtaining informed consent, participants undergo initial assessments including blood tests and imaging. They are then randomly assigned to receive either Tocilizumab or Infliximab through intravenous infusion. Follow-up assessments occur at 3 and 6 months to evaluate disease status and medication effectiveness. Additional imaging tests may be conducted to check for any new vascular problems. At the end of the study, a final assessment determines the long-term effects of treatment on disease activity and quality of life.
Summary
Currently, there is one active clinical trial available for patients with Takayasu’s arteritis. This trial is being conducted in France and focuses on comparing two biologic medications, Infliximab and Tocilizumab, for patients whose disease is refractory to standard treatment or has relapsed. The study is particularly relevant for patients seeking alternative treatment options when conventional therapies have not been successful. Both investigational drugs target different inflammatory pathways, offering hope for better disease control with reduced steroid use. Patients interested in participating should discuss eligibility with their healthcare provider and consider the comprehensive monitoring and follow-up procedures involved in the trial.
