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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 glucocorticoids and/or certain maintenance immunosuppressive medications at study entry will remain on these medications during the study. 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 in which 1) no other cause can be attributed, 2) the symptoms call for usual treatment consisting of a reinitiation or increase in glucocorticoids and/or an increase or addition of a second immunosuppressive agent other than cyclophosphamide, OR 3) disease activity is confined to one or more of the following (more 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. Merkey, MD, MPH ) |
Study ID Numbers: | RDCRN 5522 |
Study First Received: | April 30, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00468208 |
Health Authority: | United States: Federal Government |
Vasculitis Relapse Immunoglobulin Ig |
Lung Diseases, Interstitial Vasculitis Vascular Diseases Wegener's granulomatosis Cytotoxic T-lymphocyte antigen 4 Antibodies Abatacept |
Wegener Granulomatosis Respiratory Tract Diseases Urologic Diseases Lung Diseases Kidney Diseases Immunoglobulins |
Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases |
Antirheumatic Agents Immunosuppressive Agents Pharmacologic Actions |