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.
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 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；
Diagnosis of osteomyelitis；
Shanghai Institute Of Biological Products
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator