Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
NCT ID: NCT01466166
Last Updated: 2019-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
188 participants
OBSERVATIONAL
2011-11-15
2017-06-30
Brief Summary
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Detailed Description
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The design of this study follows the FDA-approved Full Prescribing Information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pegloticase
Participants received pegloticase 8 mg by intravenous (IV) infusion every 2 weeks for up to 1 year, as prescribed by their treating physician.
Pegloticase
Pegloticase 8 mg intravenous every 2 weeks
Interventions
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Pegloticase
Pegloticase 8 mg intravenous every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have made the decision, along with their treating physician, to begin treatment with KRYSTEXXA.
* Patients who are willing and able to give informed consent and adhere to visit/protocol schedules.
Exclusion Criteria
* Non-compensated congestive heart failure
* Pregnancy or breast feeding
* Prior treatment with pegloticase or another recombinant uricase
* Known allergy to urate oxidase
* Prior treatment or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug
* Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
18 Years
ALL
No
Sponsors
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Horizon Pharma Rheumatology LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Nieves, PharmD
Role: STUDY_DIRECTOR
Horizon Pharma Rheumatology LLC
Locations
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Rheumatology Associates, PC
Birmingham, Alabama, United States
UAB Rheumatology
Birmingham, Alabama, United States
Saadat Ansari, MD, LLC
Huntsville, Alabama, United States
Medvin Clinical Research
Covina, California, United States
Alliance Clinical Research, LLC
Laguna Hills, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
Pacific Arthritis Care Center
Los Angeles, California, United States
R Srinivasan, MD, Inc
Monterey Park, California, United States
Brigid Freyne, MD, Inc
Murrieta, California, United States
Alliance Clinical Research
Poway, California, United States
Denver Nephrologists, PC
Denver, Colorado, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Washington DC Veteran's Affairs Medical Center
Washington D.C., District of Columbia, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Countryside Arthritis Center
Clearwater, Florida, United States
Science and Research Institute, Inc
Jupiter, Florida, United States
A & O Research Center
Miami, Florida, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, United States
Family Clinical Trials, LLC
Pembroke Pines, Florida, United States
Jedidiah Clinical Research
Tampa, Florida, United States
Midtown Medical Center
Tampa, Florida, United States
Global Research Partners & Consultants, Inc.
Calhoun, Georgia, United States
Arthritis Research & Treatment Center
Stockbridge, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Diagnostic Rheumatology and Research PC
Indianapolis, Indiana, United States
Physicians' Clinic of Iowa, P.C.
Cedar Rapids, Iowa, United States
Central Kentucky Research Associates of Kentucky
Mount Sterling, Kentucky, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Klein & Associates MD, PA.
Hagerstown, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Clinical Pharmacology Study Groups
Worcester, Massachusetts, United States
Reliant Medical Group, Inc.
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Caro Health Plaza
Caro, Michigan, United States
Infusion Associates
Grand Rapids, Michigan, United States
Justus J. Fiechtner, MD, PC
Lansing, Michigan, United States
Shores Rheumatology, PC
Saint Clair Shores, Michigan, United States
Saint Paul Rheumatology, PA
Eagan, Minnesota, United States
Kansas City Internal Medicine
Kansas City, Missouri, United States
Arthritis Medical Clinic
Las Vegas, Nevada, United States
Rheumatology Associates of North Jersey
Teaneck, New Jersey, United States
Rheumatology Associates of Long Island
Smithtown, New York, United States
NorthEast Rheumatology
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
Shanahan Rheumatology and Immunotherapy, PLLC
Raleigh, North Carolina, United States
Specialty Medical Clinic and Research Center
Sanford, North Carolina, United States
Southern Ohio Rheumatology
Portsmouth, Ohio, United States
Keystone Pain Institute, Ilumina Clinical Associates
Altoona, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Acme Research L.L.C.
Orangeburg, South Carolina, United States
Ramesh C. Gupta, M.D.
Memphis, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Dr. Raj Marwah
El Paso, Texas, United States
Diagnostic Clinic of Houston
Houston, Texas, United States
Rheumatic Disease Clinical Research Center
Houston, Texas, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States
Arthritis & Osteoporosis Center of North Virginia
Manassas, Virginia, United States
Sentara Rheumatology Specialists
Norfolk, Virginia, United States
Apex Clinical Research
Kennewick, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Rheumatic Disease Center, LLP
Glendale, Wisconsin, United States
Countries
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References
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Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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M0401
Identifier Type: -
Identifier Source: org_study_id
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