VCRC Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu’s Arteritis .....

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: Recruiting

Summary:

Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.

Background

Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause redness and swelling of blood vessels (vasculitis). These diseases are likely to affect the large sized blood 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 18 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)

How to Participate:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

·  Cleveland Clinic Foundation (VCRC)

Cleveland, Ohio

Principal Investigator: Carol Langford, MD, MHS

Contact Person: Katherine Tuthill, RN, MSN, CNP

Office: 216-444-9606

Email: TUTHILLK@ccf.org

Participation in research studies is voluntary. Deciding not to participate in a research study does not affect your ability to receive care at any of our Clinical Centers or from other physicians.