Obinutuzumab versus Rituximab in PR3-Patients with ANCA-Associated Vasculitis (PRRR)

The main purpose of this study is to compare how patients with severe new or severe relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) respond to obinutuzumab and rituximab. In this study, you will get either obinutuzumab or rituximab. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA) for treating GPA/MPA. Obinutuzumab is investigational and is being compared to rituximab, which is approved by the FDA to treat GPA/MPA.

Information from this study may help us develop a better treatment for patients with PR3 positive ANCA-associated vasculitis.

YES. You will be randomly assigned to receive either obinutuzumab or rituximab. You will receive 2 infusions two weeks apart. You will also take prednisone that will be tapered over 17 weeks. This is a double-blind study, which means that you and the study team will not know which drug you are receiving.

We will use your personal health information, information from the tests and procedures done for the study, and information about how the drugs affect you to help determine if one drug is more effective in treating GPA/MPA than the other.

There are many factors that determine if you are eligible. Some requirements include:

· Adults with severe newly-diagnosed disease or severe relapsing disease

· Have a positive test result for PR3-ANCA

You could be in the study for up to 18 months.

The study requires 11 visits to Penn Medicine. Study procedures include review of medical history, medications, demographics, and previous therapies. You are expected to attend all study visits. During some or all of the visits, you will have physical exams, ECG (electrocardiogram), blood and urine collection, and you will complete questionnaires.

Thank you for your interest! If you wish to learn more, please contact:

Daniel Killion

rheumatologyresearch@uphs.upenn.edu

215-614-4417