A Randomized, Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
Recruiting
18-90 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: Between 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
01 Aug 2024.
Study ID: 833643
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