SELECT-GCA: Upadacitinib in Giant Cell Arteritis
CURRENTLY ENROLLING: NO
The main purpose of this study is to understand how patients with giant cell arteritis (GCA) respond to an investigational drug called upadacitinib. Upadacitinib is being tested to determine if it will work and be safe for the treatment of 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 upadacitinib and Prednisone, or placebo and Prednisone, which you will take once daily by mouth. A placebo is a harmless inactive substance (like a sugar pill). Prednisone will be tapered for either 26 or 52 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 upadacitinib 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
- You have received daily treatment with 40mg or more of prednisone at any time
The first part of the study (Period 1) takes about 1 year and includes 13 visits to Penn. The second part of the study (Period 2) will last another 1 year and includes 7 visits to Penn. You may be in this study for about 2 years.
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, ECG (electrocardiogram), chest x-rays, blood and urine collection, and complete questionnaires.