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



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:November 15, 2011
End Date:June 30, 2017

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Observational Study of the Use of KRYSTEXXA® (Pegloticase) in Adult Hyperuricemic Patients With Gout Refractory to Conventional Therapy

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.

This was a Phase 4, multicenter, open-label, single-arm observational study of pegloticase 8
mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout
refractory to conventional therapy. Study duration is approximately 63 weeks, including 51
weeks of treatment and 12 weeks of follow-up.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Austin, Texas 78731
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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Birmingham, Alabama 35205
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Birmingham, Alabama 35294
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Brandon, Florida 33511
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Caro, Michigan 48723
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Cedar Rapids, Iowa 52401
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Charleston, South Carolina 29406
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5841 S Maryland Ave
Chicago, Illinois 60637
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Clarksburg, West Virginia 26301
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Clearwater, Florida 33761
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Concord, North Carolina 28025
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Denver, Colorado 80230
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2301 Erwin Rd
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919-684-8111
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Eagan, Minnesota 55121
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Glendale, Wisconsin 53217
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Greenville, North Carolina 27834
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500 University Dr
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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