A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy (NCT00080210) | Clinical Trial Compass
CompletedPhase 2
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
United States40 participantsStarted 2004-03
Plain-language summary
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
Who can participate
Age range
18 Years – 90 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:
Subjects to be included in the study are:
* Outpatients of either gender, age 18 or older
* Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
* Hyperuricemic: screening serum uric acid must be \>=8 mg/dL.
* The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
* Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide
Exclusion Criteria:
Subjects to be excluded are those for whom any of the following apply:
* Unstable coronary artery disease or uncontrolled hypertension
* History of end stage renal disease requiring dialysis
* History of liver disease, as defined by baseline serum transaminase elevation \>3X the upper limit of normal in the absence of any other known cause
* Organ transplant recipient requiring immunosuppressive therapy
* Concurrent use of prednisone at a dose \>10 mg qd (or equivalent) at or within one week before dosing
* Concurrent use of uric acid-lowering agents
* Prior treatment …
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.