Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (GPA // Wegener's) (ABROGATE)

The main purpose of this study is to understand how patients with non-severe, relapsing granulomatosis with polyangiitis (GPA) respond to an investigational drug called abatacept (also called Orencia or CTLA4-Ig). Abatacept is being tested to determine if it is effective in treating GPA. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) for treating GPA.

YES. You will be randomly assigned to receive either abatacept or placebo. A placebo is a harmless inactive substance (like saline). You will inject the study drug under your skin once a week. You will also take prednisone that will be tapered over 26 weeks. This is a double-blind study, which means that you and the study team will not know which group you are in.

This is a clinical trial to determine the effectiveness and safety of the investigational drug, abatacept, in treating patients with granulomatosis with polyangiitis (GPA). 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.

Patients with a diagnosis of GPA and who have had active disease within the past 28 days. Participants with child bearing potential must also be on an effective means of birth control during this study.

You could be in the study for up to 5 years.

You are expected to attend all study visits and take the study drug as instructed. Each visit will last about 1-2 hours. During some or all of the visits, you will have physical exams, blood and urine collection, and complete questionnaires.

This study is closed to enrollment.