Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

Completed

Conditions studied: Refractory Chronic Gout

In brief

The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. Additionally, serious adverse events associated with pegloticase therapy will be identified.

Key facts

Study ID

NCT01466166

Run by

Horizon Pharma Rheumatology LLC

People needed

188

Starts

2011-11-15

Expected to finish

2017-06-30

Last updated by the study team

2019-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize SUA and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated.
• 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.

You may not qualify if…

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• 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

Where it is running

• 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
• Rheumatology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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