Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu Arteritis (AGATA)
Vasculitis Clinical Research Consortium
5523: Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis (AGATA)
Status: Recruiting
Background
Giant cell arteritis (GCA) and Takayasu arteritis (TAK) are types of vasculitis that affect large arteries and may involve vessels that supply blood to different parts of the body including the brain, eyes, arms, legs, lungs, kidneys, intestines, heart, and other parts. The purpose of this study is to determine if the medication abatacept is safe and effective in giant cell arteritis or Takayasu arteritis.
About this Study
In the beginning of this study, all subjects will receive abatacept (by vein) combined with standard doses of prednisone. If there is no sign of GCA or TAK at month 3, you will be assigned by chance (like flipping a coin) to continue abatacept or switch to a placebo (fake treatment or inactive look-a-like) for the rest of the study. Your total time on the study will range from 12 to 48 months (1-4 years). About 66 people will take part in this study (33 with GCA and 33 with TAK) across 4 medical centers. You will be examined by the following:
- Medical history review
- Physical exam
- Imaging (x-rays, MRI)
- Blood/urine tests
- Lung function tests
- Study questionnaires
- Skin test
Visit VCRC website for more information.
