5522: VCRC Multi-Center, Open-Label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener’s Granulomatosis (WG)

Status: Closed to Accrual

Background

Wegener's granulomatosis 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 Wegener's granulomatosis 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 Wegener's granulomatosis and to gain information about whether abatacept may be effective in the treatment of mild relapsing Wegener's granulomatosis.

About this Study

This is a treatment study, with a total of 20 people with Wegener's granulomatosis 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

Target Enrollment: 20 treated people

To be eligible to participate, you must:

  1. Have an established diagnosis of Wegener’s granulomatosis
  2. Be experiencing a relapse of Wegener's granulomatosis including one or more of the following manifestations:
    • Active sinus/nasal disease
    • Mouth ulcers
    • New skin lesions
    • Joint and/or muscle aches
    • Non severe pulmonary disease
    • Other features of mild active disease
  3. 15 years of age or older
  4. Willing and able to provide informed consent and comply with treatment and follow-up procedures
  5. Willing to use effective means of birth control while receiving treatment through this study

You are not eligible to participate if:

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