Study on Infliximab and Tocilizumab for Patients with Refractory or Relapsing Takayasu Arteritis

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What is this study about?

This clinical trial is focused on studying a condition called Takayasu arteritis, which is a rare disease that causes inflammation of the blood vessels. The study is comparing two treatments: Infliximab and Tocilizumab. Infliximab is a medication given as a powder for infusion, which means it is mixed with a liquid and given through a vein. Tocilizumab is a concentrate for solution for infusion, also administered through a vein. Both medications are used to help reduce inflammation in the body.

The purpose of the study is to evaluate the effectiveness and safety of these treatments in patients whose Takayasu arteritis is not responding well to other treatments or has returned after treatment. Participants in the study will receive either Infliximab or Tocilizumab and will be monitored over a period of time to see how well the treatment works in controlling the disease. The study aims to see if patients can maintain a low dose of a steroid medication called prednisone while keeping the disease inactive.

Throughout the study, participants will have regular check-ups to monitor their health and the activity of the disease. The study will also look at how often the disease relapses, or comes back, and whether there are any side effects from the treatments. The goal is to find out which treatment is more effective in managing Takayasu arteritis and to ensure that it is safe for patients to use.

1 joining the study

Upon joining the study, the diagnosis of Takayasu arteritis is confirmed. Eligibility is assessed based on specific criteria, including age, weight, and medical history.

A negative pregnancy test is required for female participants of child-bearing age, and contraceptive measures must be used during the study.

2 initial assessment

An initial assessment is conducted, including a chest X-ray or CT scan to rule out active infections or malignancies.

Blood tests are performed to ensure negative results for HIV, hepatitis B, and hepatitis C.

3 randomization and treatment initiation

Participants are randomly assigned to receive either tocilizumab or infliximab, both administered through intravenous infusion.

The treatment aims to achieve inactive disease status with a reduced dose of prednisone (or prednisolone) to ≤ 0.1 mg/kg per day.

4 treatment phase

The treatment phase lasts for 6 months, with regular monitoring to assess disease activity and response to medication.

Participants continue their assigned medication and are monitored for any side effects or adverse events.

5 follow-up assessments

Follow-up assessments occur at 3 and 6 months after starting treatment to evaluate disease status and medication effectiveness.

Additional tests, such as angio-CT or MR angiography, may be conducted to assess any new vascular lesions.

6 completion of study

The study concludes with a final assessment to determine the long-term effects of the treatment on disease activity and quality of life.

Participants may be asked to complete a quality of life questionnaire to provide feedback on their experience during the trial.

Who Can Join the Study?

Diagnosis of Takayasu arteritis, a specific medical condition.
Receiving medical care in a university or general hospital in France.
Having social insurance.
Willing and able to provide written informed consent, which means agreeing to participate after understanding the study details.
Recent chest X-ray or CT scan (within 12 weeks) showing no active tuberculosis, infection, or cancer.
Assessment for tuberculosis, a serious lung infection, meeting specific conditions.
Negative tests for HIV (a virus affecting the immune system), hepatitis C (a liver infection), and hepatitis B (another liver infection) within the last 3 months.
Willing and able to follow the treatment and procedures required by the study.
For women who can have children, a negative pregnancy test and no plans to become pregnant within 12 months.
For participants who can have children, agreeing to use birth control to prevent pregnancy during the study.
Having an active disease according to specific international criteria.
Having a disease that is difficult to treat or has severe symptoms affecting the arteries.
Currently using one immunosuppressive medication (like methotrexate or azathioprine) without changing the dose in the last 30 days, unless there is an allergy or other reason not to use these medications.
Being 15 years of age or older.
Weighing between 40 and 120 kg.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that could affect the study results.
Patients who are unable to follow the study procedures or take the study medication as directed.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that could interfere with their ability to participate in the study.
Patients who have been diagnosed with cancer within the last five years.
Patients who have had a major surgery within the last three months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Aoqafdmvco Pvzbxhvx Hrdjyqlu Dn Mbflcacot	Marseille	France
Ciin Dv Napna	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.02.2021

Trial locations

Investigated drugs:

Infliximab is a medication used in this trial to treat patients with Takayasu arteritis, a rare type of vasculitis that affects large blood vessels. It works by blocking a protein in the body that causes inflammation, helping to reduce symptoms and prevent disease progression.

Tocilizumab is another medication being tested in the trial for its effectiveness in treating Takayasu arteritis. It targets a specific protein involved in the immune response, helping to decrease inflammation and control the disease.

Prednisone (or prednisolone) is a corticosteroid used in the trial to manage inflammation and suppress the immune system in patients with Takayasu arteritis. It is used to help achieve disease inactivity and reduce symptoms.

Takayasu arteritis – This is a rare inflammatory disease that affects the large blood vessels, primarily the aorta and its main branches. It leads to the thickening and narrowing of these vessels, which can reduce blood flow to various parts of the body. The disease often begins with non-specific symptoms such as fatigue, fever, and muscle pain. As it progresses, it may cause more specific symptoms like weak or absent pulses, high blood pressure, and differences in blood pressure between arms. Over time, the reduced blood flow can lead to complications in organs and tissues that rely on the affected vessels. The progression of the disease can vary, with periods of activity and remission.

Trial ID:

2024-512229-10-00

Protocol code:

P160909

NCT ID:

NCT04564001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Infliximab and Tocilizumab for Patients with Refractory or Relapsing Takayasu Arteritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?