Open-Label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener’s Granulomatosis (VCRC)

Background

Wegener's granulomatosis (WG) is an illness characterized by inflammation of blood vessels. It may involve many different parts of the body, but typically affects the upper respiratory tract (nose and sinuses), the lower respiratory tract (lungs), and kidneys. The current standard treatment for WG involves various medications and is based on disease severity. Unfortunately, more than 50% of people experience a relapse after remission, placing them at risk for additional organ damage and toxicity from medication. To prevent this, safer and more effective treatments for mild-moderate relapses are needed. We especially need to find treatments to help reduce the amount of prednisone patients need to take. The purpose of this pilot study is to determine the safety of the medication abatacept in WG and to gain information about whether abatacept may be effective in the treatment of mild relapsing WG.

 About this Study

This is a treatment study, with a total of 20 people with WG taking part in this study at several hospitals. In this study abatacept is given intravenously at study visits on Days 1, 15, 29 and once a month thereafter. Participation in this study may last between 7 and 24 months. Study visits include the following:

• abatacept infusions
• blood tests; for clinical and for research purposes
• questionnaires to measure quality of life
• chest x-rays and CT scans of the chest and/or sinuses
• medical exam and physician assessment

 To be eligible to participate, you must:

• Have an established diagnosis of WG
• Be experiencing a relapse of WG including one or more of the following manifestations:
• Active sinus/nasal disease
• Mouth ulcers
• New skin lesions
• Joint and/or muscle aches
• New pulmonary disease
• Eighteen years of age or older
• Willing and able to provide informed consent and comply with treatment and follow-up procedures
• Willing to use effective means of birth control while receiving treatment through this study

 You are not eligible to participate if:

• Your relapse does not meet the criteria for mild-moderate disease
• You are taking more than 15 mg of prednisone daily
• You are being treated with cyclophosphamide (Cytoxan) at the time of enrollment
• You have been treated with rituximab within the past 12 months
• You are not able to follow study rules

How to Participate:

Please use the information below to inquire about participation.

Boston University School of Medicine, Boston, MA
Jessica Pettit
Study Coordinator
jlpettit@bu.edu
Phone: 617.414.2508

Cleveland Clinic Foundation, Cleveland, OH
Katherine Tuthill
Study Coordinator
tuthillk@ccf.org
Phone: 216.444.5257

Johns Hopkins Vasculitis Center, Baltimore, MD
Lourdes P. Sejismundo
Study Coordinator
lsejism1@jhmi.edu
Phone: 410.550.6818

University of Toronto Mount Sinai Hospital, Toronto, ON (site soon to open)
Sara Sutherland, RN BScN
Study Coordinator
SWebster2@mtsinai.on.ca

Phone: 416.586.8616