Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout (NCT00111657) | Clinical Trial Compass
CompletedPhase 2
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
United States30 participantsStarted 2004-12
Plain-language summary
The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout.
Funding Source - FDA OOPD
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Symptomatic gout
* Serum uric acid \>7 mg/dL
* Intolerance of, or inadequate response to, conventional therapy for gout
* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method
Exclusion Criteria:
* End stage renal failure that requires dialysis
* Concurrent use of uric-acid lowering agents
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* A history of anaphylactic reaction to a recombinant protein
* Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)
* A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Plasma Uric Acid to Less Than 6 mg/dL.