Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy of Tocilizumab in association to steroids in giant cell arteritis with cerebro-vascular involvement patients (ToGiAS). A french prospective multicentre randomized versus placebo phase III trial (TOGIAC)

This study is testing a new way to treat giant cell arteritis (GCA) in people whose blood vessels leading to the brain are affected. GCA is an inflammation of blood vessels, and this study specifically looks at cases where there's a risk of stroke. Researchers want to see if adding a medicine called tocilizumab to the usual steroid treatments can help people recover completely and prevent further issues like strokes. It's a 'Phase 3' study, which means it compares the new treatment with a dummy treatment (placebo) to find out if it's safe and effective. The main goal is to see if patients get better and avoid strokes over 24 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

19 Nov 2024

Giant cell arteritis with Cerebro-vascular involvement

What is this study about?

This study, called ToGiAS, is looking into the treatment of a condition called giant cell arteritis (GCA), specifically when it has affected the blood vessels that supply the brain. GCA is an inflammation of medium and large arteries, which can cause symptoms like headaches, jaw pain, and vision problems. When it affects the brain's blood supply, it can lead to more serious issues like strokes, so finding effective treatments is very important.

The study aims to find out if combining a medicine called tocilizumab with the standard steroid treatment is better than using steroids alone for people with this type of GCA. Tocilizumab is a drug that helps calm down the immune system. By comparing tocilizumab plus steroids to a dummy treatment (placebo) plus steroids, the researchers hope to understand if this new combination can lead to a full recovery and prevent future problems like strokes.

The main thing the doctors will be checking is whether patients achieve a complete recovery from their GCA, including an absence of new strokes, over 24 weeks. They will also be looking at how many people stay well without their GCA coming back, how quickly people get better, and if there are any side effects from the treatment. This research is crucial because it could offer a new and more effective way to help people with GCA that affects the brain.

Key takeaways

This study evaluates tocilizumab plus steroids for GCA affecting the brain.
It aims to prevent strokes and achieve full recovery over 24 weeks.
Compares active treatment with a dummy treatment (placebo).
Open to adults aged 18 and over with specific GCA.
Involves regular clinic visits, blood tests, and scans.
Potential benefits include better treatment; risks include side effects.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over. This study is open to both men and women.

However, it's specifically for people who have been diagnosed with giant cell arteritis (GCA) that has affected the blood vessels leading to their brain. This means the study is focused on a particular group of GCA patients. Your doctor will be able to tell you if your specific situation matches what the study is looking for.

There might be other health conditions or medications that would prevent someone from joining, even if they meet these main criteria. A study doctor would need to review your full medical history to confirm if this study is suitable for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Giant Cell Arteritis (GCA)?
Has your GCA affected the blood vessels that lead to your brain?
Are you able to attend regular hospital visits for check-ups and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the active medicine, tocilizumab, along with standard steroid treatment, or a dummy medicine (placebo) along with standard steroid treatment. The study is 'blinded', meaning neither you nor your study doctor will know which treatment you are receiving.

Over the course of the study, you would have several visits to the clinic for assessments. These would likely include physical check-ups, blood tests, and scans like MRI to monitor your condition and check for any improvement or side effects. These assessments would happen at specific times, including at 4, 12, 24, and 52 weeks after starting the treatment.

The main part of the study will last for 24 weeks, where they will check if your GCA has gone into complete remission and if you've avoided any new strokes. You would then continue to be followed for up to 52 weeks to keep an eye on your progress and any long-term effects. This helps researchers understand the full picture of the treatment's impact.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that could be more effective than standard care for your type of GCA, potentially leading to a better recovery and preventing future strokes. You would also have very close monitoring of your health. However, there's a chance you might receive the dummy treatment, meaning you wouldn’t get the active study medication. Potential risks of tocilizumab include side effects like stuffy nose, headaches, high blood pressure, and reactions where the injection is given. More serious, but less common, side effects can include infections (especially in the upper airways), rare liver problems, a drop in certain white blood cells, and high cholesterol. Your safety will be carefully monitored throughout the study, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What is giant cell arteritis (GCA)?

GCA is a condition where the blood vessels, especially in the head and neck, become inflamed. It can cause headaches, jaw pain, and sometimes more serious problems like vision loss or strokes if it affects blood vessels supplying the brain.

What is tocilizumab?

Tocilizumab is a medicine that works by calming down your immune system. It's used to treat certain conditions where the immune system is overactive and causing inflammation.

Why is this study important for people with GCA?

This study aims to find a better way to treat GCA, especially for those whose brains are affected. If successful, it could offer a new treatment that helps people recover fully and prevents serious problems like strokes.

What does 'placebo' mean in a study?

A placebo is a dummy treatment, which looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the active treatment fairly.

How long would I be involved in the study?

The main treatment and assessment period covers 24 weeks, but you would be followed up for a total of 52 weeks to monitor your health and recovery.