A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
CURRENTLY ENROLLING: YES
The main purpose of this study is to understand how patients with giant cell arteritis (GCA) respond to an investigational drug called abatacept (also called Orencia). Abatacept is being tested to determine if it is effective in treating GCA. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) for treating GCA.
YES. You will be randomly assigned to receive either abatacept or placebo. A placebo is a harmless inactive substance (like saline). You will inject the study drug under your skin once a week. You will also take prednisone that will be tapered over 26 weeks. This is a double-blind study, which means that you and the study team will not know which group you are in.
We will use your personal health information, information from the tests and procedures done for the study, and information about how the study drug affects you to help determine if the study drug abatacept is safe and effective in treating GCA.
There are many factors that determine if you are eligible. Some requirements include:
- Patients with a new GCA diagnosis or those with disease relapse
- Men and women 50 years or older
If you have disease remission, you will be in the study for up to 18 months and have 8 visits to Penn. If you do not respond to study treatment or have a relapse, you will have the option to begin taking open-label abatacept. Open-label means that there is no placebo. You could be in this part of the study for up to 18 months.
You are expected to attend all study visits and take the study drug as instructed. Each visit will last about 1-2 hours. During some or all of the visits, you will have physical exams, blood and urine collection, and complete questionnaires.