Status: Recruiting

For Diseases

• Giant cell arteritis

Background

Giant cell arteritis (GCA) belongs to a family of diseases characterized by vasculitis (inflammation of blood vessels in your body). The cause of GCA is unknown, but we do know that it is a condition in which your body's own immune system is causing inflammation and injury to your own blood vessels and tissues.

The current treatment for GCA includes glucocorticoids (steroids such as prednisone) given alone or potentially with a second medication. Although glucocorticoids can be effective, they are associated with a number of side effects and they do not always prevent the occurrence of disease relapses.

The purpose of this study is to find out whether the medication abatacept (which is also called Orencia or CTLA4-Ig) is effective in the treatment of patients with newly diagnosed or relapsing GCA.

About this Study

78 participants with vasculitis will join this study. In this study, participants will be randomly assigned by chance (like flipping a coin) to either receive abatacept or a placebo (inactive solution that looks like the study medicine but it doesn't contain abatacept) injected subcutaneously (by syringe) combined with standard doses of prednisone. If you are already receiving methotrexate when you join the study (you will not be allowed to start this as a new medication while you are in the study), you should continue taking the same dose of this medication (unless you are told by a study doctor to decrease the amount for safety reasons).

While on the study, if your symptoms come back and you have a relapse or if you have not improved after 3 months of being on the study, you will have the option of receiving open-label abatacept, which means that you will receive abatacept and there is no randomization and no placebo involved. The decision to receive open-label abatacept is your choice. If you decide not to receive this, you will stop all study medication treatment and be treated with the best medical approach as you and your doctor decide upon.

You will be asked to participate in the study for approximately 18 months (up to 8 visits). About 78 people will take part in this study across 20 medical centers in the US, Canada, and Europe.

At each study visit, you will receive the following:

• Medical history review
• Physical exam
• Blood/urine tests
• Study questionnaires

Target Enrollment

To be eligible to participate, patients must meet all of the following criteria in order to be eligible for enrollment:

• You must have a diagnosis of giant cell arteritis (GCA)
• You must have a presence of active GCA within the past 8 weeks
• You must be willing and able to follow treatment and follow-up procedures
• You must be willing and able to provide informed consent to participate

You are not eligible to participate if:

• You have signs of an infection, or have active tuberculosis
• You are not able to follow study guidelines
• You have significantly reduced number of blood cells
• You received recent treatment with another medicine too soon to enrolling into this study
• You are believed to need oral or IV glucocorticoid treatment during the trial for conditions other than GCA

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.