AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)

This research study, called ABAGART, is investigating a new treatment for Giant Cell Arteritis (GCA). GCA is a condition where blood vessels become inflamed. The study is comparing a medicine called abatacept against a dummy treatment (placebo) to see if abatacept can help people with GCA go into remission, meaning their symptoms go away or are much less severe. We're particularly interested in how many people are in remission after 12 months and how safe the new medicine is. We'll also be looking at how the treatment affects patients' quality of life and if it can help them reduce their need for other medicines, particularly steroids. This is a Phase III study, which means it's a large trial to confirm if the new medicine works and is safe before it might be made more widely available.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Trustees Of The University Of Pennsylvania

Enrolment target

Start

11 Jul 2025

Giant Cell Arteritis

What is this study about?

This study, known as ABAGART, is investigating a new medicine called abatacept for people who have a condition called Giant Cell Arteritis (GCA). GCA is an illness where the body's immune system mistakenly attacks its own blood vessels, causing them to become inflamed, especially in the head and neck. This can lead to headaches, jaw pain, vision problems, and other serious issues. Current treatments often involve steroid medications, which can have side effects when used for a long time.

The main goal of this study is to find out if abatacept can help people with GCA achieve `remission`. `Remission` means that the symptoms of GCA have gone away or are much reduced, and the condition is under control. Researchers want to see how many people taking abatacept are in remission after 12 months compared to those taking a `placebo` – which is an inactive substance that looks just like the real medicine but contains no active drug. This helps them understand whether any improvements are truly due to the abatacept.

Beyond simply achieving remission, the study also looks at other important aspects. Researchers will carefully check for any side effects of abatacept to make sure it's safe. They will also look at how patients feel and how their quality of life changes, using special questionnaires. Another key aim is to see if abatacept can help people reduce or stop taking steroid medications, which is often a goal for people with GCA due to potential long-term side effects of steroids.

Key takeaways

This study is testing a new medicine (abatacept) for Giant Cell Arteritis (GCA).
It compares abatacept to a dummy medicine (placebo) to see if it helps GCA go into remission.
The main focus is on how many people are well after 12 months and the medicine's safety.
Researchers will also look at how treatment affects your quality of life and steroid use.
It's a large-scale study which means it's a final step before potential broader use.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. There is no upper age limit, so people of all adult ages can be considered. This study is open to both men and women.

Because this is a specific study for Giant Cell Arteritis, you would need to have received a diagnosis of GCA from your doctor. The research team will review your medical history and current health carefully to make sure the study is right for you and that you meet all other specific criteria, such as the stage of your GCA.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Giant Cell Arteritis (GCA)?
Are you able to attend regular clinic visits?
Are you comfortable with the possibility of receiving a placebo (dummy medicine)?
Are you willing to have regular blood tests and health checks?
Are you open to completing questionnaires about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the new medicine (abatacept) or a dummy medicine (placebo) as an injection. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the results are fair. The abatacept comes in a pre-filled syringe.

You would have regular visits to the hospital or clinic for assessments. These visits would involve health checks, blood tests, and discussions about how you are feeling and any symptoms you might have. You would also complete questionnaires about your quality of life. The study medication is given for a period, and you would be followed up closely for 12 months in total, with ongoing monitoring beyond that for safety. The total duration of your active involvement with receiving treatment and regular check-ups would be carefully explained to you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could help manage your GCA and improve your quality of life, potentially reducing your need for other medicines like steroids. However, there's no guarantee that the treatment will work for you, or that you will receive the active drug. There's also a chance you could experience side effects from the study medication, some of which may be unknown. The study team will monitor your health very closely to identify and manage any potential side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany

Common questions

What is Giant Cell Arteritis (GCA)?

GCA is a condition where your immune system causes inflammation in blood vessels, particularly in your head and neck, which can cause symptoms like headaches and vision changes.

What is abatacept?

Abatacept is the new medicine being tested in this study. It aims to help control the inflammation caused by GCA.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.

What does 'remission' mean in this study?

Remission means your GCA symptoms are gone or significantly reduced, and the condition is under control.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your doctors will know. This 'double-blind' approach ensures unbiased results.