A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

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…