Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis
Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness of the medication abatacept in treating adults with mild relapsing WG.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Open-label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis|
- Safety of abatacept [ Time Frame: Measured monthly during study and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: Yes ]
- Efficacy of abatacept [ Time Frame: Measured monthly during study and 1, 3, and 6 months post-treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Participants will receive abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter for a total of 6 to 18 months.
A participant's abatacept dose will depend on body weight and will remain the same throughout the study:
Abatacept will be administered in a 30-minute intravenous infusion.
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 medication toxicity. To prevent this, safer and more effective treatments for mild relapses are needed. Several studies have shown that activated T cells, a type of white blood cell important in regulating immune responses, play a role in WG. Abatacept, an immunoglobulin-based medication approved by the FDA to treat rheumatoid arthritis, acts by preventing T-cell activation and may be useful in treating mild relapses of WG. The purpose of this study is to determine the safety and effectiveness of abatacept in treating adults with mild relapsing WG.
Participation in this study may last between 7 and 24 months. Participants will receive abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter. A participant's abatacept dose will depend on body weight and will remain the same throughout the study. Participants who are receiving maintenance immunosuppressive medications consisting of methotrexate, azathioprine, or mycophenolate mofetil at the time of enrollment will remain on these medications without dosage increase or reduction. Eligible participants may be receiving up to prednisone 15mg daily at the time of relapse. Following the development of relapse, participants may be treated with up to prednisone 30mg daily if necessary, but must be back to the same dose that they had been on prior to relapse by Month 2. All study visits will include medication review, physical exam, blood and urine collection, and questionnaires. A chest x-ray, computed tomography (CT) scan of the chest and sinuses, and lung function testing may occur at some study visits. Participants whose symptoms have not improved by Month 2 will stop receiving abatacept. All participants will attend three follow-up study visits that will occur 1, 3, and 6 months after the end of treatment.
|United States, Maryland|
|The Johns Hopkins Vasculitis Center|
|Baltimore, Maryland, United States, 21224|
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|United States, Minnesota|
|Mayo Clinic College of Medicine|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Carol A. Langford, MD, MHS||The Cleveland Clinic|
|Principal Investigator:||Peter A. Merkel, MD, MPH||Boston University|