RecruitingPHASE3INTERVENTIONAL

Abatacept for the Treatment of Giant Cell Arteritis

This research study is investigating a new medicine called abatacept for people with Giant Cell Arteritis (GCA). GCA is a condition where blood vessels become inflamed. This study wants to find out how well abatacept works compared to a 'dummy' treatment (placebo) in managing GCA. We're looking for 62 people with GCA that has either just been diagnosed or has come back after a period of improvement. Participants will receive either abatacept or a placebo injection each week. The study will look at how many people achieve a stable period without symptoms. If the condition doesn't improve or comes back during the first year, participants might be offered abatacept openly for up to another year. This study aims to help us understand if abatacept could be a useful new option for treating GCA.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Pennsylvania

Enrolment target

Start

29 Mar 2021

Estimated completion

01 Dec 2029

Giant Cell Arteritis

What is this study about?

This study is looking into a condition called Giant Cell Arteritis, often shortened to GCA. GCA causes inflammation in your blood vessels, particularly those in your head and neck, but it can affect others too. This inflammation can lead to a variety of symptoms like headaches, jaw pain, or even problems with your vision. Currently, standard treatments are available, but doctors are always looking for new and better ways to help people.

This research is testing a medicine called abatacept. It's hoped that abatacept might help control the inflammation caused by GCA and prevent the condition from getting worse or coming back. To understand if abatacept truly works, the study will compare it to a 'placebo', which is like a dummy treatment that doesn't contain any active medicine. This allows researchers to see if any improvements are due to the abatacept itself, or other factors.

The study will involve people who have recently been diagnosed with GCA, or those whose GCA has returned after being under control. By carefully comparing the effects of abatacept and the placebo in a group of people, doctors can learn whether this new treatment is safe and effective for GCA. This kind of study is really important for developing new medicines that could improve the lives of people with conditions like GCA.

Key takeaways

The study tests a new medicine, abatacept, for Giant Cell Arteritis (GCA).
It’s for people with newly diagnosed or recently returned GCA.
Participants will get weekly injections of either abatacept or a placebo.
The study aims to see if abatacept can help keep GCA in remission.
Close medical monitoring and care will be provided throughout.

Who may be eligible?

To join this study, you would generally need to be 50 years old or older. You must have been diagnosed with Giant Cell Arteritis (GCA) recently, or had your GCA come back within the last eight weeks. Importantly, doctors need to see signs that your GCA is currently active when you join.

There are also some reasons why you might not be able to take part. For example, if you've had a serious infection that needed hospital treatment or strong antibiotics in the last two months, or a milder infection that needed antibiotics or antiviral medicine in the last month, you likely wouldn't be able to join. Your doctor will check for other health conditions as well to make sure the study is safe for you.

It's very important that you can understand what the study involves and are happy to follow the study's instructions. If you're a woman who could become pregnant, you'd need to agree to use effective birth control throughout your time in the study.

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 50 years old or older?
Have you been diagnosed with GCA recently (within the last 8 weeks) or has your GCA come back in that timeframe?
Do you have current signs that your GCA is active?
Are you able and willing to follow all study instructions and attend appointments?
If you could get pregnant, are you willing to use effective birth control during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you’ll be randomly assigned to either receive the abatacept medicine or a placebo (a dummy treatment). You won't know which one you're getting, and neither will your local doctor or the study team. Both the abatacept and the placebo are given as an injection under the skin once a week.

For the first 12 months, you'll continue with your weekly injections. If your GCA goes into remission (meaning your symptoms improve and stabilise), you’ll stay on your assigned treatment for this full year. After 12 months, if you've been well, the abatacept or placebo will be stopped. However, if your GCA doesn't improve by month 3, or if it comes back within the first 12 months, there will be an option for you to receive the actual abatacept medicine openly for up to another 12 months. This means you and your doctor would know you are receiving the real drug.

You will have regular appointments for check-ups, blood tests, and to assess your GCA symptoms and general health. The total duration of your participation in the study could be up to two years, depending on whether you achieve remission and if you choose to receive open-label abatacept.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive abatacept, which could help manage your GCA better than current treatments. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee that the treatment will work for you, and if you receive the placebo, you might not see any direct benefit from the study medicine itself. Abatacept, like all medicines, can have side effects, and these would be explained to you in detail by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Hospital for Special Surgery
Verified postcode
New York, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Vanderbilt University
Verified postcode
Nashville, United States· Recruiting
University of British Columbia
Verified postcode
Vancouver, Canada· Recruiting
St. Joseph's Healthcare
Verified postcode
Hamilton, Canada· Recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting
Hôpital du Sacré-Coeur de Montréal Université de Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Giant Cell Arteritis (GCA)?

GCA is a condition where arteries (blood vessels) become inflamed, especially in and around your head. It can cause headaches, jaw pain, and other symptoms.

What is abatacept?

Abatacept is a type of medicine that helps to control the immune system, which is believed to play a role in GCA inflammation.

What does 'placebo-controlled' mean?

It means some people will get the active medicine, and others will get a 'dummy' treatment that looks the same but has no medicine in it. This helps doctors see if the medicine really works.

How will I take the study treatment?

The study treatment (either abatacept or placebo) is given as an injection under the skin once a week.

What if my GCA gets worse during the study?

If your GCA doesn't improve or gets worse in the first year, you might have the option to receive the actual abatacept medicine openly, for up to another year.

How to find out more

Carol McAlear, MA

cmcalear@pennmedicine.upenn.edu 7813214567 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.