5523: Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu’s Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis (AGATA)

Status: Closed to Accrual

Background

Giant cell arteritis (GCA) and Takayasu's 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's 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

Target Enrollment:

To be eligible to participate, you must:

  1. have a diagnosis of GCA or TAK
  2. have presence of GCA or TAK within the past 2 months
  3. be 15 years of age or older
  4. be willing and able to follow treatment and follow-up procedures
  5. be willing to use an effective means of birth control during this study
  6. be willing and able to give written informed consent

You are not eligible to participate if:

  1. you have signs of an infection
  2. you are pregnant or breast feeding
  3. you are infected with HIV, hepatitis C, or hepatitis B
  4. you are not able to follow study guidelines
  5. you are not able to give informed consent
  6. you have a reduced number of blood cells
  7. you have a poor kidney(s)

 

Download the protocol document