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

Recruiting
18 years - 90 years
All
Phase 3
10 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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.  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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Giant Cell Arteritis,GCA,vasculitis
  • Age: 18 years - 90 years
  • Gender: All

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

Updated on 14 Jan 2026. Study ID: 19-0727

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