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Sponsors and Collaborators: |
Office of Rare Diseases (ORD) Rare Diseases Clinical Research Network |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00468208 |
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.
Condition | Intervention | Phase |
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Wegener's Granulomatosis |
Drug: Abatacept |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label Pilot Study of Abatacept (CTLA4-Ig) in the Treatment of Mild Relapsing Wegener's Granulomatosis |
Estimated Enrollment: | 20 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: Abatacept
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapse of WG within the past 28 days where disease activity is confined to one or more of the following sites and where the symptoms/signs are of such a nature that the usual treatment would consist of the reinstitution or increase in GC to no more than prednisone 30mg daily and/or an increase or addition of a second immunosuppressive agent other than CYC (more specific information about this criterion can be found in the protocol):
Exclusion Criteria:
United States, Maryland | |
The Johns Hopkins Vasculitis Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Lourdes P. Sejismundo 410-550-6818 lsejism1@jhmi.edu | |
Principal Investigator: Phil Seo, MD | |
United States, Massachusetts | |
Boston University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Jessica Pettit 617-414-2508 jlpettit@bu.edu | |
Principal Investigator: Peter A. Merkel, MD, MPH | |
Principal Investigator: Paul A. Monach, MD | |
United States, Minnesota | |
Mayo Clinic College of Medicine | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Kathleen Mieras 507-284-9187 mieras.kathleen@mayo.edu | |
Principal Investigator: Ulrich Specks, MD | |
Principal Investigator: Eric L. Matteson, MD, MPH | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Katherine Tuthill 216-444-9606 tuthillk@ccf.org | |
Principal Investigator: Carol A. Langford, MD, MHS | |
Principal Investigator: Gary S. Hoffman, MD, MS |
Principal Investigator: | Carol A. Langford, MD, MHS | Cleveland Clinic |
Principal Investigator: | Peter A. Merkel, MD, MPH | Boston University |
Responsible Party: | Boston University School of Medicine ( Peter A. Merkel, MD, MPH ) |
Study ID Numbers: | RDCRN 5522 |
Study First Received: | April 30, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00468208 History of Changes |
Health Authority: | United States: Federal Government |
Vasculitis Relapse Wegener's Treatment |
Lung Diseases, Interstitial Vasculitis Immunologic Factors Vascular Diseases Immunosuppressive Agents Cytotoxic T-lymphocyte antigen 4 Abatacept |
Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Wegener's Granulomatosis Kidney Diseases Antirheumatic Agents |
Lung Diseases, Interstitial Vasculitis Immunologic Factors Physiological Effects of Drugs Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Abatacept |
Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Therapeutic Uses Cardiovascular Diseases Kidney Diseases Antirheumatic Agents |