Study on Tocilizumab and Steroids for Patients with Giant Cell Arteritis and Cerebrovascular Involvement

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What is this study about?

This clinical trial is focused on studying the effectiveness of a medication called Tocilizumab in treating a condition known as Giant Cell Arteritis with cerebrovascular involvement. Giant Cell Arteritis is a disease that causes inflammation of the blood vessels, which can lead to complications such as strokes. The study aims to see if Tocilizumab, when used alongside steroids, can help patients achieve complete remission, meaning the disease is no longer active, and prevent the recurrence of strokes as seen through clinical assessments and MRI scans over a period of 24 weeks.

Participants in the study will receive either Tocilizumab or a placebo, which is a substance with no active medication. The treatment is administered as a solution for injection under the skin. The study will monitor the participants’ health and progress at various intervals, specifically at weeks 4, 12, 24, and 52, to assess the effectiveness of the treatment in preventing disease relapse and improving neurovascular imaging results. The safety of Tocilizumab will also be evaluated by observing any adverse events, such as infections or changes in blood pressure.

The goal of this research is to determine if Tocilizumab can effectively manage Giant Cell Arteritis with cerebrovascular involvement and reduce the need for steroids, which are commonly used to treat this condition. By understanding the potential benefits and risks of Tocilizumab, the study hopes to provide valuable insights into better treatment options for patients with this challenging disease.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being over 60 years old and having a diagnosis of giant cell arteritis with cerebrovascular involvement.

The patient must sign an informed consent form and be affiliated with social security.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis and evaluate the patient’s condition.

This includes clinical evaluations and imaging tests such as PET scans or MRI to assess arterial involvement.

3 treatment initiation

The patient begins treatment with either tocilizumab or a placebo, administered via subcutaneous injection.

The treatment is combined with steroids, and the dosage and frequency are determined by the study protocol.

4 monitoring and follow-up

The patient’s progress is monitored at weeks 4, 12, 24, and 52 to assess the effectiveness of the treatment.

This includes evaluating remission of symptoms, imaging improvements, and any adverse events.

5 completion of the study

The study aims to assess the primary endpoint of complete remission and absence of stroke recurrence at 24 weeks.

Secondary endpoints include relapse-free survival, time to remission, and safety assessments.

Who Can Join the Study?

You must be older than 60 years.
You need to have a diagnosis of Giant Cell Arteritis (GCA). This is a condition that affects the blood vessels, and the diagnosis can be confirmed by specific criteria or a positive test from a small sample of an artery.
You must have neurovascular involvement, which means the blood vessels in your brain or neck are affected. This can be shown by certain tests like PET scans or MRI/CT scans.
If you have had an ischemic stroke or a Transient Ischemic Attack (TIA), which are types of strokes, it should be in specific areas of the brain.
If you have not had a stroke, your condition should still show signs of blood vessel involvement without symptoms.
If you are a “symptomatic” patient, you should join the study within 4 weeks after your stroke.
If you are an “asymptomatic” patient, you should join the study within 4 weeks after your GCA diagnosis or relapse.
You should join the study within 21 days after starting treatment with corticosteroids, which are medications used to reduce inflammation.
You must sign a form that shows you understand the study and agree to participate.
You need to be affiliated with social security.

Who Cannot Join the Study?

Patients who have a different medical condition than Giant cell arteritis with cerebrovascular involvement. This condition involves inflammation of blood vessels, which can affect blood flow to the brain.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Beaujon	Clichy	France
Guvshb Hljjovdeqfd Uxacdeeyfmrhf Pmrpb Pizvsnxvwao El Nhpvftaroflj	Paris	France
Cuu Kbtzkct Bqtpllb	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.09.2021

Trial locations

Investigated drugs:

Tocilizumab

Tocilizumab is a medication used in this trial to help reduce inflammation in patients with giant cell arteritis, a condition that affects blood vessels. It is being tested to see if it can help patients achieve complete remission and prevent further complications like strokes.

Steroids are used in this trial alongside tocilizumab. They are commonly used to reduce inflammation and suppress the immune system, which can help manage symptoms and prevent damage in conditions like giant cell arteritis.

Investigated diseases:

Giant cell arteritis

Giant Cell Arteritis with Cerebrovascular Involvement – This is a form of vasculitis, which is an inflammation of the blood vessels, specifically affecting the large and medium arteries in the head. It can lead to headaches, scalp tenderness, jaw pain, and vision problems. When it involves the blood vessels supplying the brain, it can cause symptoms related to cerebrovascular issues, such as strokes or transient ischemic attacks. The disease progresses as the inflammation causes narrowing or blockage of the affected arteries, potentially leading to reduced blood flow. This can result in complications like ischemic strokes if not managed properly. The condition is considered rare and requires careful monitoring to prevent serious outcomes.

Trial ID:

2024-511906-21-00

Protocol code:

APHP191062

NCT ID:

NCT04888221

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tocilizumab and Steroids for Patients with Giant Cell Arteritis and Cerebrovascular Involvement

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?