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 |
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.
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.
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
67
sites
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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