Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect (NCT02598596) | Clinical Trial Compass
CompletedPhase 2
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
United States132 participantsStarted 2015-12
Plain-language summary
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level \<6 mg/dL, in patients with chronic, refractory gout.
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
. Adult (age ≥18 years) men and women of non-childbearing potential, 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.
. Hyperuricemic - Screening visit SUA must be \>6 mg/dL
. On gout flare prophylactic regimen for 7 days prior to the first dose.
. Willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed)
Exclusion criteria
. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (confirmed at Screening visit)
. Non-compensated congestive heart failure, uncontrolled arrhythmia, treatment for acute coronary syndrome (ACS) (myocardial infarction or unstable angina) or hospitalization for congestive heart failure within 3 months of screening or uncontrolled blood pressure (\>160/100 mm Hg) at baseline (Screening and pre-dose at Week 1 visit )
. Women of childbearing potential defined as:
. Prior treatment with pegloticase or another recombinant uricase
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
Normalization of serum uric acid (SUA) in subjects receiving a tolerizing regimen of pegloticase
Timeframe: Week 17
2
Normalization of serum uric acid (SUA) in subjects receiving pegloticase and azathioprine (AZA) immunosuppressive therapy
. Prior treatment or concomitant therapy with a polyethylene glycol (PEG) conjugated drug
. Known allergy to PEG products or history of anaphylactic reaction to a recombinant protein or porcine product
. Concurrent treatment with urate lowering agents (ULAs), such as allopurinol and febuxostat. Patients treated with these medications must discontinue treatment 7 days prior to the first dose of study drug
. Recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study