A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontro… (NCT06298071) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
China36 participantsStarted 2023-03-03
Plain-language summary
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.
Who can participate
Age range
18 Years – 70 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:
* Willing and able to give informed consent.
* Male and female aged between 18 and 70 years old , regardless of gender.
* Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30)；
* The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol/L at screening；
* Patients whose serum uric acid level could not reach the target after standard treatment with conventional uric acid-lowering drugs or who were contraindicated or intolerant to conventional uric acid-lowering drugs；
* Patients who were willing to stop taking any uric-acid-lowering drug at least 7 days before using methotrexate during the run-in period;
* Could tolerate the prescribed dose of methotrexate during the run-in period;
* Patients were able to attend and complete the visit on time.
Exclusion Criteria:
* Patients had active systemic infection within 2 weeks before enrollment，including an infection for which treatment was being received；
* Having a chronic or recurrent infection, such as recurrent pneumonia or chronic bronchitis; Patients with active or severe lung disease or pulmonary insufficiency on chest imaging, or current pulmonary fibrosis or bronchiectasis；
* Patients who are on anti-TB treatment or have active TB；
* Dia…
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
AE(Adverse Events)
Timeframe: 14 weeks after the first dose
2
SAE(Serious Adverse Events)
Timeframe: 14 weeks after the first dose
3
AUC(Area Under The Plasma Concentration Versus Time Curve)
Timeframe: 14 weeks after the first dose
4
Cmax(Peak Plasma Concentration)
Timeframe: 14 weeks after the first dose
5
Tmax(Peak Time)
Timeframe: 14 weeks after the first dose
6
T ½ (Terminal elimination half-life)
Timeframe: 14 weeks after the first dose
7
CL (Clearance Rate)
Timeframe: 14 weeks after the first dose
8
ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody)