CompletedNot Applicable

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

United States188 participantsStarted 2011-11-15

Plain-language summary

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.

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: * 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

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

Number of Participants With Infusion Reactions

Timeframe: 52 weeks

Number of Participants With Anaphylaxis

Timeframe: 52 weeks

Number of Participants With Immune Complex-related Events

Timeframe: From first dose of study drug to the end of the 12-week follow-up period (63 weeks).

Trial details

NCT IDNCT01466166

SponsorHorizon Pharma Rheumatology LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-06-30

Results submitted2018-06-29

View on ClinicalTrials.gov More Refractory Chronic Gout trials