Granulomatosis with Polyangiitis (Wegener's)
GPA belongs to a family of diseases characterized by vasculitis (inflammation of blood vessels in your body). The cause of GPA 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 degree of this inflammation and how GPA is affecting your blood vessels and tissues can be further viewed as being severe or non-severe.
Standard treatment of GPA is a combination of drugs including glucocorticoids (steroids such as prednisone) and a second drug to suppress the body's immune system. Despite these treatments, relapses occur in most people. Because of this, it is important to identify new treatment options that are effective and allow prednisone to be stopped, particularly for non-severe disease.
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 non-severe, relapsing GPA.
About 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, azathioprine (also called Imuran), mycophenolate (also called cellcept or myfortic), or leflunomide (also called arava) you would continue taking the same dose of this medication.
While on the study, if your symptoms come back and you have a non-serious disease relapse or if you have not improved after 6 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.
Your total time on the study will range from 12 to 48 months (1-4 years). About 150 people will take part in this study across 30 medical centers in the US, Canada, Mexico, Europe and Australia.
At each study visit, you will receive the following:
- Medical history review
- Physical exam
- Blood/urine tests
- Study questionnaires
To be eligible to participate, you must:
- have a diagnosis of GPA (also known as Wegener's)
- have presence of active non-severe GPA within the past 28 days
- be 15 years of age or older
- be willing and able to follow treatment and follow-up procedures
- be willing to use an effective means of birth control during this study
- be willing and able to give written informed consent
You are not eligible to participate if:
- you have signs of an infection
- you are pregnant or breastfeeding
- you are infected with HIV, hepatitis C, hepatitis B or have active tuberculosis
- you are not able to follow study guidelines
- you are not able to give informed consent
- you have significantly reduced number of blood cells
- you have a poor kidney function